A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Adults and Adolescents With Erythropoietic Protoporphyria or X-Linked Protoporphyria

To investigate the efficacy of MT-7117 on time to onset and severity of first prodromal symptoms (burning, tingling, itching, or stinging) associated with sunlight exposure in adults and adolescents with EPP or XLP.

开始日期2023-12-11

申办/合作机构

Mitsubishi Tanabe Pharma America, Inc.初创企业

NCT05276349 / CompletedN/AIIT

Home-based Remote Digital Monitoring to Assess ALS Progression (Track ALS)

The purpose of this study is to study use of advance Digital Health Technologies (DHT) and its validity as measures for assessing progression in Amyotrophic Lateral Sclerosis (ALS) patients. A total of 80 ALS patients will be recruited across US, and will involve two sites - St. Joseph Hospital and Medical Center in Phoenix, AZ, and Emory University ALS Clinic in Atlanta. This will be a fully remote observational study and will employ remote data collection platforms such as (a) A digital spirometry device powered by a mobile app will be used to measure vital capacity; (b) A clinical-grade voice recording app will be used to evaluate speech function; (c) A medical-grade wearable sensor will be used to monitor activity levels and sleep patterns; and (d) Standardized Electronic Clinical Outcome Assessments (eCOA) and Patient Reported Outcomes (ePRO) will be used to evaluate quality of life and cognitive abilities.
The main goals of this study is to answer some of these questions:
1. Can ALS patients measure important aspects of disease progression at home, either by themselves with appropriate training or with assistance of a coordinators via virtual visit?
2. Which clinical outcome measures collected through DHT are sensitive indicators of ALS progression?
3. Are the measures reproducible and whether they can correlate with gold standard assessments?
The results of this study have the potential to provide valuable information for designing future ALS trials that are more decentralized, more patient-centric, and require less visits to the clinic which typically become a major burden with disease progression

开始日期2022-02-21

申办/合作机构

St. Joseph's Medical Center, Inc.

[+2]

NCT05241535 / Completed临床1期

A Phase 1, Randomized, Partial Double-Blind, Placebo- and Positive-Controlled, Three-way Crossover Study to Evaluate the Effect of MT-7117 on the QT/QTc Interval in Healthy Subjects

The purpose of this study is to evaluate the effect of a single oral dose of MT-7117 on the QT/QTc interval in healthy subjects.

开始日期2022-01-12

申办/合作机构

Mitsubishi Tanabe Pharma America, Inc.初创企业

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项与 Mitsubishi Tanabe Pharma America, Inc. 相关的文献（医药）

2024-12-01·JOURNAL OF THE NEUROLOGICAL SCIENCES

Efficacy of Radicava® IV (intravenous edaravone) in subjects with differing trajectories of disease progression in amyotrophic lateral sclerosis: Use of a novel statistical approach for post hoc analysis of a pivotal phase 3 clinical trial

Article

作者: Pioro, Erik P ; Liu, Ying ; Brooks, Benjamin Rix ; Pioro, Erik P. ; Apple, Stephen ; Zhang, Jeffrey

INTRODUCTION:

Subjects with amyotrophic lateral sclerosis (ALS) treated with Radicava® (edaravone) IV (intravenous; Mitsubishi Tanabe Pharma America [MTPA], hereafter "MTPA IV edaravone") in Study MCI186-19 had a significantly slower physical functional decline vs placebo-treated subjects as measured by the revised ALS Functional Rating Scale (ALSFRS-R) and analyzed by the linear mixed model for repeated measures (MMRM). This Study 19 post hoc analysis of MTPA IV edaravone-treated and placebo-treated subjects evaluated linear and nonlinear latent class mixed models defining trajectories based on identifying the model with the lowest Bayesian information criterion. The best model differentiated 4 nonlinear trajectories in ALS subjects. ALSFRS-R total score in MTPA IV edaravone-treated and placebo-treated subjects was evaluated for these 4 nonlinear latent class trajectory groups.

METHODS:

Disease trajectories of MCI186-19 MTPA IV edaravone-treated or placebo-treated ALS subjects who completed the double-blind period were investigated using latent class analysis (LCA) statistical models to identify potential unique nonlinear ALSFRS-R disease trajectories.

RESULTS:

ALSFRS-R trajectories revealed 4 unique nonlinear trajectory latent classes per treatment group in MTPA IV edaravone-treated and placebo-treated ALS subjects completing the MCI186-19 double-blind period. Latent classes 2-4 had statistically significant slowing of ALSFRS-R total score decline in the predicted nonlinear trajectories of MTPA IV edaravone-treated vs placebo-treated ALS subjects.

CONCLUSIONS:

This post hoc analysis suggests MTPA IV edaravone treatment results in slower ALSFRS-R decline vs placebo in most predicted nonlinear trajectories. LCA is a novel approach that may benefit future trial analyses.

2023-10-01·Muscle & nerve

The effects of intervention with intravenous edaravone in Study 19 on hospitalization, tracheostomy, ventilation, and death in patients with amyotrophic lateral sclerosis

Article

作者: Takahashi, Fumihiro ; Pioro, Erik P ; Hagan, Melissa ; Brooks, Benjamin Rix ; Apple, Stephen ; Sakata, Takeshi

Abstract:

Introduction/Aims:

Intravenous (IV) edaravone is a US Food and Drug Administration–approved treatment for amyotrophic lateral sclerosis (ALS), shown in clinical trials to slow physical functional decline. In this study we compared the effect of IV edaravone (edaravone‐first group) versus placebo followed by IV edaravone (placebo‐first group) on survival and additional milestone events.

Methods:

This work is a post hoc analysis of Study 19/MCI186‐19, which was a randomized, placebo‐controlled, phase 3 study investigating IV edaravone versus placebo. Study 19 and its 24‐week extension have been described previously (NCT01492686). Edaravone‐first versus placebo‐first group time to events for specific milestone(s) were analyzed post hoc. Time‐to‐event composite endpoints were time to death; time to death, tracheostomy, or permanent assisted ventilation (PAV); and time to death, tracheostomy, PAV, or hospitalization.

Results:

The risk for death, tracheostomy, PAV, or hospitalization was 53% lower among patients in the edaravone‐first vs placebo‐first groups (hazard ratio = 0.47 [95% confidence interval 0.25 to 0.88], P = .02). The overall effect of IV edaravone on ALS progression could be seen in the significant separation of time‐to‐event curves for time to death, tracheostomy, PAV, or hospitalization. ALS survival composite endpoint analyses (ALS/SURV) suggested a treatment benefit (least‐squares mean difference) for the edaravone‐first versus the placebo‐first group at week 24 (0.15 ± 0.05 [95% confidence interval 0.06 to 0.25], P < .01) and week 48 (0.11 ± 0.05 [95% confidence interval 0.02 to 0.21], P = .02).

Discussion:

These analyses illustrate the value of timely and continued IV edaravone treatment, as earlier initiation was associated with a lower risk of death, tracheostomy, PAV, or hospitalization in patients with ALS.

2023-06-29·The New England journal of medicine1区 · 医学

Dersimelagon in Erythropoietic Protoporphyrias

1区 · 医学

Letter

作者: Belongie, Kirstine ; Balwani, Manisha ; Desnick, Robert J

项与 Mitsubishi Tanabe Pharma America, Inc. 相关的新闻（医药）

2024-12-17

·PRNewswire

Mitsubishi Tanabe Pharma America Announces Research Collaboration Between Mitsubishi Tanabe Pharma Corporation and Dewpoint Therapeutics to Advance Small Molecule Condensate Modulator for ALS

Collaboration aims to address underlying ALS pathology with innovative TDP-43 modulator technology JERSEY CITY, N.J., Dec. 17, 2024 /PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced that Mitsubishi Tanabe Pharma Corporation (MTPC), its parent company and a global leader in neurological disease therapeutics, has entered into a strategic research collaboration with Dewpoint Therapeutics, Inc. The collaboration focuses on developing a novel TDP-43 small molecule condensate modulator (c-mod) for amyotrophic lateral sclerosis (ALS), furthering MTPC's commitment to advancing innovation in ALS and central nervous system (CNS) diseases. Under the terms of the agreement, MTPC will pay Dewpoint an upfront payment. Upon reaching certain pre-specified milestones, MTPC will have the exclusive option to license the program and assume responsibility for global clinical development and commercialization. "ALS remains one of the most challenging diseases to treat, with limited treatment options for patients," said Yasutoshi Kawakami, President, MTPA. "Through this collaboration with Dewpoint Therapeutics, we hope to advance innovative approaches to address this devastating disease by leveraging their expertise in condensate biology. Together, we are committed to making a meaningful difference for patients living with ALS." The TDP-43 small molecule condensate modulator is being developed to target key underlying biological mechanisms associated with ALS. TDP-43 is a protein known to play a critical role in ALS pathology, where its dysregulation contributes to neuronal cell death and dysfunction. This innovative approach seeks to address TDP-43's pathological aggregation, with the potential to advance understanding of ALS. This collaboration reflects MTPC's continued focus on central nervous system diseases, including ALS. With the development of RADICAVA® (edaravone) and RADICAVA ORS® (edaravone), MTPC remains a global leader in advancing ALS care and is committed to addressing the unmet needs of patients and families living with ALS. About Mitsubishi Tanabe Pharma America, Inc. Based in Jersey City, N.J., Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC). It was established by MTPC to develop and advance our pipeline as well as commercialize approved pharmaceutical products in North America. For more information, please visit or follow us on X (formerly Twitter), Facebook and LinkedIn. About Mitsubishi Tanabe Pharma Corporation Mitsubishi Tanabe Pharma Corporation (MTPC), the pharma arm of Mitsubishi Chemical Group (MCG), is one of the oldest pharmaceutical companies in the world, founded in 1678, and focusing on ethical pharmaceuticals. MTPC is headquartered in Doshomachi, Osaka, the birthplace of Japan's pharmaceutical industry. MTPC sets the MISSION of "Creating hope for all facing illness". To that end, MTPC is working on the disease areas of central nervous system, immuno-inflammation, diabetes and kidney, and cancer. MTPC is focusing on "precision medicine" to provide drugs with high treatment satisfaction by identifying patient populations with high potential for efficacy and safety. In addition, MTPC is working to develop "around the pill solutions" to address specific patient concerns based on therapeutic medicine, including prevention of diseases, pre-symptomatic disease care, prevention of aggravation and prognosis. For more information, go to . About Condensate Condensates are membraneless organelles that form dynamically throughout the cell via a process called phase separation. These subcellular compartments organize and concentrate biomolecules within cells to enable a diversity of key biochemical processes. The dysregulation of biomolecular condensates has been observed in many diseases, including cancer, diabetes, cardiovascular, and neurological disorders. Condensate modulators (cmods) potentially provide novel therapeutic options for complex diseases and historically undruggable targets. Media inquiries: [email protected] SOURCE Mitsubishi Tanabe Pharma America WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

引进/卖出

2024-12-04

·PRNewswire

Mitsubishi Tanabe Pharma America to Present Data on Investigational ND0612 at the 2024 Annual Meeting of the Parkinson Study Group

JERSEY CITY, N.J., Dec. 4, 2024 /PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced the presentation of two abstracts on investigational ND0612 in Parkinson's disease (PD) at the 2024 Annual Meeting of the Parkinson Study Group (PSG), being held December 5-8 in Nashville, Tenn. ND0612 is being evaluated as a 24-hour, continuous, subcutaneous (SC) infusion of liquid levodopa/carbidopa (LD/CD). "We look forward to attending the PSG meeting where we will discuss our latest findings on investigational ND0612 with other experts from the scientific community," said Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs, MTPA. "This ongoing research is driven by our passion to support the Parkinson's disease community and continue investigating areas of significant unmet needs for patients." MTPA's posters will be presented in Grand Hall A, B & C on December 5, 5:00 p.m.-7:00 p.m. CST: Presentation Details: Presentations will discuss outcomes from the open-label, Phase 2b BeyoND study (NCT02726386), which evaluated the safety and efficacy of investigational ND0612 over three years in people with PD experiencing motor fluctuations, as well as a characterization of infusion site reactions (ISRs) reported from treatment with ND0612 in clinical studies. Continuous Subcutaneous Levodopa/Carbidopa Infusion with ND0612 for Parkinson's Disease: Three-Year Data from the Open-Label BeyoND Study (Jonathan Pereira, M.D.; MTPA) Characterization of Infusion Site Reactions (ISRs) with 24-Hour Subcutaneous Infusion of ND0612: Findings from an Integrated Safety Database (Jonathan Pereira, M.D.; MTPA) About ND0612 ND0612 is an investigational drug-device combination therapy – a 24-hours/day, continuous subcutaneous (SC) infusion of liquid levodopa/carbidopa (LD/CD) for the treatment of motor fluctuations in people with Parkinson's disease (PD). Development of investigational ND0612 is being led by NeuroDerm, Ltd., a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC). About Mitsubishi Tanabe Pharma America, Inc. Based in Jersey City, N.J., Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC). It was established by MTPC to develop and advance our pipeline as well as commercialize approved pharmaceutical products in North America. For more information, please visit or follow us on X (formerly Twitter), Facebook and LinkedIn. About Mitsubishi Tanabe Pharma Corporation Mitsubishi Tanabe Pharma Corporation (MTPC), the pharma arm of Mitsubishi Chemical Group (MCG), is one of the oldest pharmaceutical companies in the world, founded in 1678, and focusing on ethical pharmaceuticals. MTPC is headquartered in Doshomachi, Osaka, the birthplace of Japan's pharmaceutical industry. MTPC sets the MISSION of "Creating hope for all facing illness". To that end, MTPC is working on the disease areas of central nervous system, immuno-inflammation, diabetes and kidney, and cancer. MTPC is focusing on "precision medicine" to provide drugs with high treatment satisfaction by identifying patient populations with high potential for efficacy and safety. In addition, MTPC is working to develop "around the pill solutions" to address specific patient concerns based on therapeutic medicine, including prevention of diseases, pre-symptomatic disease care, prevention of aggravation and prognosis. For more information, go to About NeuroDerm, Ltd. NeuroDerm, Ltd. is a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC), based in Israel, inspired to reduce disease burden and improve the quality of life of patients and their families through innovative drug-device combination therapies and technologies. NeuroDerm is an integrated pharmaceutical and medical technology company developing central nervous system (CNS) product candidates. For additional information, please visit NeuroDerm's website at or follow the Company on LinkedIn. Media inquiries: [email protected] SOURCE Mitsubishi Tanabe Pharma America WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床2期

2024-12-03

·PRNewswire

Mitsubishi Tanabe Pharma America to Present New ALS Research at MNDA's 35th International Symposium on ALS/MND

JERSEY CITY, N.J., Dec. 3, 2024 /PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced 10 presentations covering advances in amyotrophic lateral sclerosis (ALS) research at the Motor Neurone Disease Association (MNDA) 35th International Symposium on ALS/MND, being held in Montreal, Canada, from December 6-8. "We are honored to participate in this year's MNDA symposium, where we will share insights from our preclinical, clinical and real-world studies on RADICAVA® (edaravone) and RADICAVA ORS® (edaravone) and discuss the evolving ALS treatment landscape," said Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs at MTPA. "Our commitment to advancing ALS research is underscored by over eight years of continuous contributions at this symposium. This dedication guides us in leveraging both clinical and real-world evidence to help support the ALS community." RADICAVA ORS Results: Final results from two multi-center, Phase 3b, double-blind, parallel group studies will be presented, including a comparison of daily dosing of RADICAVA ORS (edaravone) with the FDA-approved on/off regimen, assessed over 48 weeks (MT-1186-A02) and up to 96 weeks (MT-1186-A04). Additionally, safety data from a Phase 3 open-label safety extension study (MT-1196-A03) will be shared. Phase 3b Study MT-1186-A02 to Investigate the Superiority of Daily Dosing vs the FDA-approved On/Off Regimen of Oral Edaravone in Patients with ALS (Alejandro Salah, M.D., Ph.D., MBA, MHA; MTPA) Poster Session B: 5:30 p.m. – 7:00 p.m. ET, Saturday, December 7 Phase 3, Open-Label, Safety Extension Study of Oral Edaravone Administered Over 96 Weeks in Patients with ALS (MT-1186-A03) (Alejandro Salah, M.D., Ph.D., MBA, MHA; MTPA) Poster Session B: 5:30 p.m. – 7:00 p.m. ET, Saturday, December 7 Phase 3b Study MT-1186-A04 Extension Study to Evaluate the Continued Efficacy and Safety of Radicava ORS® (Oral Edaravone) for up to an Additional 48-Weeks in Patients With Amyotrophic Lateral Sclerosis (Stephen Apple, M.D.; MTPA) Poster Session B: 5:30 p.m. – 7:00 p.m. ET, Saturday, December 7 Real World Data: Presentations will highlight the evolving ALS treatment landscape with insights from the ALS/Motor Neuron Disease (MND) Natural History Consortium (NHC) registry covering treatment patterns, clinical outcomes and survival rates in RADICAVA-treated individuals. Additional presentations include a preliminary analysis of the OPTUM claims database, evaluating treatment combinations in people with ALS. Further highlights include studies on point-of-care quality assessment and at-home telespirometry, evaluating erect and supine slow vital capacity measurements in people with ALS. Evolution of the Treatment Landscape for Patients Diagnosed With ALS in the United States (Malgorzata Ciepielewska, M.S.; MTPA) Poster Session B: 5:30 p.m. – 7:00 p.m. ET, Saturday, December 7 Treatment Patterns and Survival Benefit of Edaravone–Treated People With Amyotrophic Lateral Sclerosis in the ALS/MND Natural History Consortium (Malgorzata Ciepielewska, M.S.; MTPA) Oral Session 2B – Improving Clinical Management: 10:30 a.m. – 12:30 p.m. ET, Friday, December 6 Preliminary Analysis of Treatment Combinations in Patients With Amyotrophic Lateral Sclerosis Enrolled in an US-Based Administrative Claims Database (Malgorzata Ciepielewska, M.S.; MTPA) Poster Session B: 5:30 p.m. – 7:00 p.m. ET, Saturday, December 7 Smartphone Application–Mediated Supervised At-Home Telespirometry Erect and Supine Slow Vital Capacity (eSVC/sSVC) Measurements in Subjects With Amyotrophic Lateral Sclerosis Identify Statistically Significant Differences in eSVC/sSVC Decline as Function of Non-Invasive Ventilation Treatment Status [NCT05106569] (Eufrosina I. Young, M.D.; SUNY Upstate Medical University) Poster Session B: 5:30 p.m. – 7:00 p.m. ET, Saturday, December 7 Smartphone Application–Mediated, Supervised, At-Home Telespirometry Vital Capacity Measurements in Amyotrophic Lateral Sclerosis: Comparison of American Thoracic Society/European Respiratory Society Point-of-Care Quality Assessment Algorithms Implemented for Slow Vital Capacity and Forced Vital Capacity [NCT05106569] (Eufrosina I. Young, M.D.; SUNY Upstate Medical University) Poster Session B: 5:30 p.m. – 7:00 p.m. ET, Saturday, December 7 Preclinical Data: Two preclinical studies will be presented, showcasing key mechanisms in ALS pathology. The first study demonstrates edaravone's role in modulating glutamate-mediated hyperexcitability in spinal motor neurons, using an ALS animal model. The second study explores how LRSAM1 contributes to TDP-43 clearance, a critical process in ALS, using induced pluripotent stem cells (iPSCs) derived from ALS patients. Edaravone Reduces the Enhanced Glutamatergic Transmission Onto Motor Neurons in the Spinal Cord of a Mouse Model of Amyotrophic Lateral Sclerosis (Yun Kyung Park, Ph.D.; MTPC) Poster Session B: 5:30 p.m. – 7:00 p.m. ET, Saturday, December 7 LRSAM1 Protects Neurons in Amyotrophic Lateral Sclerosis by Regulating the TDP-43 Proteostasis (Takayuki Shirakawa, Ph.D.; MTPA) Oral Session 6A – Proteostasis and Proteotoxicity: 10:30 a.m. – 12:30 p.m. ET, Saturday, December 7 About RADICAVA® (edaravone) and RADICAVA ORS® (edaravone) The U.S. Food and Drug Administration (FDA) approved RADICAVA® (edaravone) on May 5, 2017, and the oral formulation RADICAVA ORS ® (edaravone) on May 12, 2022, for the treatment of amyotrophic lateral sclerosis (ALS). In 2024, the FDA recognized RADICAVA ORS with Orphan Drug Exclusivity based on the major contribution to patient care of the innovative oral formulation. RADICAVA is administered in 28-day cycles by intravenous (IV) infusion. It takes 60 minutes to receive each 60 mg dose. For the initial cycle, the treatment is infused daily for 14 consecutive days, followed by a two-week drug-free period. All cycles thereafter are infused daily for 10 days within a 14-day period, followed by a two-week drug-free period. RADICAVA ORS is taken daily for 14 consecutive days followed by a 14-day drug-free period for the initial treatment cycle. For subsequent treatment cycles, RADICAVA ORS is taken for 10 days within a 14-day period followed by a 14-day drug-free period. RADICAVA ORS should be taken in the morning after overnight fasting. Patients should not eat or drink (except water) within one hour after taking RADICAVA ORS.1 Edaravone was discovered and developed for ALS by Mitsubishi Tanabe Pharma Corporation (MTPC) and commercialized in the U.S. by Mitsubishi Tanabe Pharma America, Inc. (MTPA). The MTPC group companies began researching ALS in 2001 through an iterative clinical platform over a 13-year period. In 2015, edaravone was approved as RADICUT® for the treatment of ALS in Japan and South Korea. Marketing authorizations were subsequently granted in Canada (October 2018), Switzerland (January 2019), Indonesia (July 2020), Thailand (April 2021), Malaysia (December 2021) and Brazil (February 2024). Marketing authorization for RADICAVA® Oral Suspension was granted in Canada (November 2022) and Switzerland (May 2023), and RADICUT® Oral Suspension 2.1% was granted regulatory approval in Japan in December 2022. To date, in the U.S., RADICAVA and RADICAVA ORS have been used to treat over 16,000 people with ALS, with over 2.0-million days of therapy, and have been prescribed by over 2,400 HCPs.2-4 IMPORTANT SAFETY INFORMATION Hypersensitivity Reactions RADICAVA (edaravone) and RADICAVA ORS (edaravone) are contraindicated in patients with a history of hypersensitivity to edaravone or any of the inactive ingredients of this product. Hypersensitivity reactions (redness, wheals, and erythema multiforme) and cases of anaphylaxis (urticaria, decreased blood pressure, and dyspnea) have occurred with RADICAVA. Patients should be monitored carefully for hypersensitivity reactions. If hypersensitivity reactions occur, discontinue RADICAVA or RADICAVA ORS, treat per standard of care, and monitor until the condition resolves. Sulfite Allergic Reactions RADICAVA and RADICAVA ORS contain sodium bisulfite, a sulfite that may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown but occurs more frequently in asthmatic people. Adverse Reactions The most common adverse reactions (≥10%) reported in RADICAVA-treated patients were contusion (15%), gait disturbance (13%), and headache (10%). In an open label study, fatigue was also observed in 7.6% of patients receiving RADICAVA ORS. Pregnancy Based on animal data, RADICAVA and RADICAVA ORS may cause fetal harm. To report suspected adverse reactions or product complaints, contact Mitsubishi Tanabe Pharma America, Inc., at 1-888-292-0058. You may also report suspected adverse reactions to the FDA at 1-800-FDA-1088 or . INDICATION RADICAVA and RADICAVA ORS are indicated for the treatment of amyotrophic lateral sclerosis (ALS). For more information, including full Prescribing Information, please visit . About Mitsubishi Tanabe Pharma America, Inc. Based in Jersey City, N.J., Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC). It was established by MTPC to develop and advance our pipeline as well as commercialize approved pharmaceutical products in North America. For more information, please visit or follow us on X (formerly Twitter), Facebook and LinkedIn. About Mitsubishi Tanabe Pharma Corporation Mitsubishi Tanabe Pharma Corporation (MTPC), the pharma arm of Mitsubishi Chemical Group (MCG), is one of the oldest pharmaceutical companies in the world, founded in 1678, and focusing on ethical pharmaceuticals. MTPC is headquartered in Doshomachi, Osaka, the birthplace of Japan's pharmaceutical industry. MTPC sets the MISSION of "Creating hope for all facing illness". To that end, MTPC is working on the disease areas of central nervous system, immuno-inflammation, diabetes and kidney, and cancer. MTPC is focusing on "precision medicine" to provide drugs with high treatment satisfaction by identifying patient populations with high potential for efficacy and safety. In addition, MTPC is working to develop "around the pill solutions" to address specific patient concerns based on therapeutic medicine, including prevention of diseases, pre-symptomatic disease care, prevention of aggravation and prognosis. For more information, go to Media inquiries: [email protected] 1 RADICAVA and RADICAVA ORS Prescribing Information. Jersey City, NJ: Mitsubishi Tanabe Pharma America, Inc.; 2022. 2 Data on file. Mitsubishi Tanabe Pharma America, Inc. 3 Data on file. Mitsubishi Tanabe Pharma America, Inc. 4 Data on file. Mitsubishi Tanabe Pharma America, Inc. SOURCE Mitsubishi Tanabe Pharma America WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

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