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Phathom Pharmaceuticals
to Present
VOQUEZNA
® (
vonoprazan
) Data at DDW 2024 Annual Meeting
2024-05-15
·
交易
·
BioSpace
临床3期
First oral presentation of Phase 3 dataevaluating the investigational use of
VOQUEZNA
® in
Non-Erosive Reflux Disease (NERD)1
New research on
Erosive gastroesophageal reflux disease (GERD)
demonstrating high health care resource utilization, real world treatment patterns in newly diagnosed patients and diagnostic accuracy of grading disease severity, to be presented2,3,4 FLORHAM PARK, N.J., May 15, 2024 (GLOBE NEWSWIRE) --
Phathom Pharmaceuticals, Inc.
(Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for
gastrointestinal (GI) diseases
, today announced that the company will present data from multiple studies for its first-in-class treatment
VOQUEZNA
® (
vonoprazan
) including an oral presentation at
Digestive Disease
Week® (DDW) 2024, being held May 18-21 in Washington, D.C.
Phathom
’s Phase 3 results evaluating the investigational use of
VOQUEZNA
in Non-Erosive Reflux Disease (NERD) will be featured in an oral presentation during the congress.1 In addition, poster presentations showcasing real-world evidence on suboptimal treatment patterns of newly diagnosed
Erosive GERD
patients treated with
proton pump
inhibitors (PPIs), and an analysis highlighting high healthcare resource utilization (HCRU) costs associated with
Erosive GERD
, among other important clinical data updates and broader clinical sessions, will be showcased. 2,3,4 “This year’s abstracts showcase the breadth of the data we will be presenting at DDW, reaffirming
Phathom
’s continued commitment to helping improve the lives of people affected by
acid-related gastrointestinal disorders
,” said Eckhard Leifke, M.D., Chief Medical Officer at
Phathom
. “Notably, we are excited to unveil novel findings highlighted in three posters and an oral presentation during the conference, including the first time data from our Phase 3 study of the investigational use of
VOQUEZNA
in
Non-Erosive GERD
will be presented during a medical congress. Our team eagerly anticipates meaningful interactions with physicians that treat the conditions we are working to transform.”
Phathom
announced in December 2023 that the
U.S. Food and Drug Administration (FDA)
accepted for review the company’s New Drug Application (NDA) for
VOQUEZNA
as a daily treatment of
heartburn
associated with
Non-Erosive GERD
and assigned a Prescription Drug User Fee Act (PDUFA) target action date of July 19, 2024. In addition to these three poster sessions and one oral presentation,
Phathom
will sponsor a product theater highlighting
VOQUEZNA
as an approved treatment for
Erosive Esophagitis
, also referred to as
Erosive GERD
, and will also have a presence on the exhibit floor at booth #911 throughout the conference. A high-level schedule of
Phathom
activities at DDW 2024 can be found below: Sunday, May 19, 2024 Certified DDW 2024 Symposium: What’s New in the Treatment of
Erosive Esophagitis
and
Gastroesophageal Reflux Disease
Time: 6:00-8:00 pm ET Presenters: Prakash Gyawali, M.D.; Rena Yadlapati, M.D.; Leila Kia, M.D. Independent CME sponsored by
Phathom Pharmaceuticals
Monday,May20,2024 Comparison of Local Investigator-Reported vs Centrally Adjudicated Los Angeles Grades of
Erosive Esophagitis
in Patients Screened for Participation in a Randomized Trial3 Time: 12:30 pm ET Presentation #: 4034836 Poster Session Real-world Treatment Patterns Among Newly Diagnosed Patients with
Erosive Esophagitis
in the U.S.4 Time: 12:30 pm ET Presentation #: 4036034 Poster Session VOQUEZNA® (
vonoprazan
) Product Theater – The Power to Help Heal and Maintain Healing of
Erosive GERD
in Adults: A Novel Treatment with First-in-Class Acid Suppression Time: 12:50 pm ET Product theater #2 Oral Presentation by Dr. Brooks D. Cash, M.D., Chief of the Division of Gastroenterology, Hepatology, and Nutrition at the
University of Texas Health Science Center
at Houston
Vonoprazan
for the Treatment of
Heartburn
in
Non-Erosive Reflux Disease
: A Randomized Trial1 Time: 4:45 pm ET Presentation #: 4025446 Oral Presentation Tuesday,May21, 2024
Erosive Esophagitis
is Associated with High Health Care Resource Utilization and Frequent Changes in Medications2 Time: 2:30 pm ET Presentation #: 4036411 Poster Session Following the meeting, abstracts will be available on the Phathom’spublicationsandscientificsection of the company website. VOQUEZNA is marketed exclusively by
Phathom Pharmaceuticals, Inc.
Please visit VoqueznaPro.com to learn more about VOQUEZNA. AboutDDW
Digestive Disease
Week® (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of
Liver Diseases
(AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW takes place May 18-21, 2024 in Washington, D.C. The meeting showcases more than 3,500 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at . INDICATION AND IMPORTANT SAFETY INFORMATION What is VOQUEZNA?
VOQUEZNA
® (
vonoprazan
) is a prescription medicine used in adults: for the healing of all grades of
Erosive Esophagitis
(
Erosive Gastroesophageal Reflux Disease
or
Erosive GERD
) and relief of
heartburn
associated with
Erosive GERD
in adults. for the maintenance of healing of all grades of
Erosive GERD
and relief of
heartburn
associated with
Erosive GERD
in adults. IMPORTANTSAFETY INFORMATION CONTRAINDICATIONS VOQUEZNA is contraindicated in patients with a known
hypersensitivity
to
vonoprazan
or any component of
VOQUEZNA
, or in patients receiving
rilpivirine
-containing products. WARNINGSANDPRECAUTIONS PresenceofGastricMalignancy: In adults, symptomatic response to therapy with
VOQUEZNA
does not preclude the presence of
gastric malignancy
. Consider additional follow-up and diagnostic testing in patients who have a suboptimal response or an early symptomatic relapse after completing treatment with
VOQUEZNA
. In older patients, also consider endoscopy. AcuteTubulointerstitialNephritis:
Acute tubulointerstitial nephritis (TIN)
has been reported with VOQUEZNA. If suspected, discontinue VOQUEZNA and evaluate patients with suspected acute TIN.
Clostridioides difficile-Associated Diarrhea
: Published observational studies suggest that proton pump inhibitors (PPIs) may be associated with an increased risk of
Clostridioidesdifficile-associated diarrhea (CDAD)
, especially in hospitalized patients. VOQUEZNA may also increase the risk of CDAD. Consider
CDAD
in patients with
diarrhea
that does not improve. Use the shortest duration of VOQUEZNA appropriate to the condition being treated. Bone Fracture: Several published observational studies suggest that PPI therapy may be associated with an increased risk for
osteoporosis-related fractures
of the hip, wrist, or spine, especially in patients receiving high dose (multiple daily doses) and long-term therapy (a year or longer).
Bone fracture
, including
osteoporosis-related fracture
, has also been reported with
vonoprazan
. Use the shortest duration of VOQUEZNA appropriate to the condition being treated. Patients at risk for
osteoporosis-related fractures
should be managed according to the established treatment guidelines. SevereCutaneousAdverseReactions(SCAR): Severe cutaneous adverse reactions, including
Stevens-Johnson syndrome (SJS)
and
toxic epidermal necrolysis (TEN)
have been reported with
VOQUEZNA
. Discontinue VOQUEZNA at the first signs or symptoms of
SCAR
or other signs of
hypersensitivity
and consider further evaluation. VitaminB12(Cobalamin)Deficiency: Long-term use of acid-suppressing drugs can lead to malabsorption of Vitamin B12 caused by hypo- or
achlorhydria
.
Vitamin B12 deficiency
has been reported postmarketing with
vonoprazan
. If clinical symptoms consistent with
vitamin B12 deficiency
are observed in patients treated with
VOQUEZNA
, consider further workup. HypomagnesemiaandMineralMetabolism: Hypomagnesemia has been reported postmarketing with
vonoprazan
.
Hypomagnesemia
may lead to
hypocalcemia
and/or
hypokalemia
and may exacerbate underlying
hypocalcemia
in at-risk patients. Consider monitoring magnesium levels prior to initiation of VOQUEZNA and periodically in patients expected to be on prolonged treatment, in patients taking drugs that may have increased toxicity in the presence of
hypomagnesemia
or drugs that may cause
hypomagnesemia
. Treatment of
hypomagnesemia
may require magnesium replacement and discontinuation of
VOQUEZNA
. Consider monitoring magnesium and calcium levels prior to initiation of
VOQUEZNA
and periodically while on treatment in patients with a preexisting risk of
hypocalcemia
. Supplement with magnesium and/or calcium, as necessary. If hypocalcemia is refractory to treatment, consider discontinuing
VOQUEZNA
. InteractionswithDiagnosticInvestigationsforNeuroendocrineTumors: Serum chromogranin A (CgA) levels increase secondary to drug-induced decreases in gastric acidity. The increased
CgA
level may cause false positive results in diagnostic investigations for
neuroendocrine tumors
. Temporarily discontinue
VOQUEZNA
treatment at least 14 days before assessing
CgA
levels and consider repeating the test if initial
CgA
levels are high. Fundic Gland Polyps: Use of
VOQUEZNA
is associated with a risk of
fundic gland polyps
that increases with long-term use, especially beyond one year. Fundic gland polyps have been reported with
vonoprazan
in clinical trials and during postmarketing use with PPIs. Most patients who developed
fundic gland polyps
were asymptomatic and
fundic gland polyps
were identified incidentally on endoscopy. Use the shortest duration of VOQUEZNA appropriate to the condition being treated. ADVERSEREACTIONS: HealingofErosiveGERD: The most common adverse reactions (≥2% of patients in the
VOQUEZNA
arm) include
gastritis
(3%),
diarrhea
(2%),
abdominal distention
(2%),
abdominal pain
(2%), and
nausea
(2%). Maintenance of Healed
Erosive GERD
: The most common adverse reactions (≥3% of patients in the VOQUEZNA arm) include
gastritis
(6%),
abdominal pain
(4%),
dyspepsia
(4%),
hypertension
(3%), and
urinary tract infection
(3%). DRUGINTERACTIONS VOQUEZNA has the potential for clinically important drug interactions, including interactions with drugs dependent on gastric pH for absorption, drugs that are substrates for certain CYP enzymes, and some diagnostic tests. Avoid concomitant use of
VOQUEZNA
with
atazanavir
or
nelfinavir
. See full Prescribing Information for more details about important drug interactions. Consult the labeling of concomitantly used drugs to obtain further information about interactions with
vonoprazan
. USEINSPECIFICPOPULATIONS Lactation: Breastfeeding is not recommended during treatment. Because of the potential risk of adverse liver effects shown in animal studies with
vonoprazan
, advise patients not to breastfeed during treatment with
VOQUEZNA
. RenalImpairment: For the healing of
Erosive GERD
, dosage reduction is recommended in patients with severe
renal impairment
(eGFR < 30 mL/min). HepaticImpairment: For the healing of
Erosive GERD
, dosage reduction is recommended in patients with moderate to severe hepatic impairment (Child-Pugh Class B and C). You are encouraged to report suspected adverse reactions by contacting
Phathom Pharmaceuticals
at 1-888-775-PHAT (7428) or
FDA
at 1-800-FDA-1088 or . Please see full Prescribing Information for VOQUEZNA. About
Erosive GERD
(
gastroesophageal reflux disease
)
Erosive GERD
, also referred to as
Erosive Esophagitis (EE)
, is a subtype of
gastroesophageal reflux disease (GERD)
characterized by erosions in the gastric mucosa caused by acidic reflux of stomach contents into the esophagus.5 There are estimated to be over 65 million individuals with
GERD
in the U.S., of which approximately 30% have
Erosive GERD.6,7,8
In addition to experiencing troubling
heartburn
symptoms, patients with inadequately treated
Erosive GERD
may progress to more severe diseases including
Barrett’s esophagus
and esophageal cancer.6 About
VOQUEZNA
®
VOQUEZNA
® (
vonoprazan
) tablets contain
vonoprazan
, an oral small molecule potassium-competitive acid blocker (PCAB).
PCABs
are a novel class of medicines that block acid secretion in the stomach.
Phathom
in-licensed the U.S. rights to
vonoprazan
from
Takeda
, which markets the product in Japan and numerous other countries in Asia and Latin America. About
Phathom Pharmaceuticals, Inc.
Phathom Pharmaceuticals
is a biopharmaceutical company focused on the development and commercialization of novel treatments for
gastrointestinal diseases
.
Phathom
has in-licensed the exclusive rights to
vonoprazan
, a first-in-class potassium-competitive acid blocker (PCAB) that is currently marketed in the United States as
VOQUEZNA
® (
vonoprazan
) tablets for the treatment of
Erosive GERD
and relief of related
heartburn
in adults, in addition to
VOQUEZNA
® TRIPLE PAK® (
vonoprazan
tablets, amoxicillin capsules,
clarithromycin
tablets) and
VOQUEZNA
® DUAL PAK® (
vonoprazan
tablets, amoxicillin capsules) for the treatment of
H. pylori infection
in adults. For more information about
Phathom
, visit the company’s website at and follow on LinkedIn and X. Forward Looking Statement This press release contains forward-looking statements. Investors are cautioned not to place undue reliance on these forward-looking statements, including statements about the PDUFA action date for and
FDA
approval of the Company’s NDA for NERD and
vonoprazan
’s ability to treat patients affected by
acid-related gastrointestinal disorders
. The inclusion of forward-looking statements should not be regarded as a representation by
Phathom
that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in
Phathom
’s business, including, without limitation: we may not be able to successfully commercialize VOQUEZNA, VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK, which will depend on a number of factors including coverage and reimbursement levels from governmental authorities and health insurers as well as market acceptance by healthcare providers; risks inherent in the clinical development of
vonoprazan
;
Phathom
’s dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; regulatory developments in the United States and foreign countries; unexpected adverse side effects or inadequate efficacy of vonoprazan that may limit its development, regulatory approval and/or commercialization, or may result in recalls or product liability claims;
Phathom
’s ability to obtain and maintain intellectual property protection and non-patent regulatory exclusivity for vonoprazan; and other risks described in the Company’s prior press releases and the Company’s filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and
Phathom
undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. MEDIA CONTACT Nick Benedetto 1-877-742-8466 media@phathompharma.com INVESTOR CONTACT Eric Sciorilli 1-877-742-8466 ir@phathompharma.com References: Loren Laine, MD, et. al.;
Vonoprazan
for The Treatment of
Heartburn
in
Non-Erosive Reflux Disease
: A Randomized Trial;
Digestive Disease
Week® (DDW) 2024 abstract; May 18-21, Washington, D.C. Nicholas J. Shaheen, et. al.;
Erosive Esophagitis
Is Associated With High Health Care Resource Utilization And Frequent Changes In Medications;
Digestive Disease
Week® (DDW) 2024 abstract; May 18-21, Washington, D.C. Stuart J. Spechler, M.D., et. al.; Comparison of Local Investigator-Reported vs Centrally Adjudicated Los Angeles Grades of
Erosive Esophagitis
in Patients Screened for Participation in a Randomized Trial;
Digestive Disease
Week® (DDW) 2024 abstract; May 18-21, Washington, D.C. Dhyanesh Arvind Patel, et. al.; Real-World Treatment Patterns Among Newly Diagnosed Patients with
Erosive Esophagitis
in The U.S.;
Digestive Disease
Week® (DDW) 2024 abstract; May 18-21, Washington, D.C. Dickman R, Maradey-Romero C, Gingold-Belfer R, Fass R. Unmet Needs in the Treatment of
Gastroesophageal Reflux Disease
. J Neurogastroenterol Motil. 2015 Jul 30;21(3):309-19. doi: 10.5056/jnm15105. Savarino E, de Bortoli N, De Cassan C, et al. The natural history of
gastro-esophageal reflux disease
: A comprehensive review. Dis Esophagus. 2017;30(2):1-9. Machicado J.D., Greer J.B., Yadav D. (2020) Epidemiology of
Gastrointestinal Diseases
. In: Pitchumoni C., Dharmarajan T. (eds) Geriatric Gastroenterology. Springer, Cham. U.S. Census Bureau. U.S. and World Population Clock. Accessed May 2022. . © 2024 Phathom Pharmaceuticals. All rights reserved. VOQUEZNA, Phathom Pharmaceuticals, and their respective logos are registered trademarks of Phathom Pharmaceuticals, Inc. 4/24 US-VPZ-24-0154
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机构
Phathom Pharmaceuticals, Inc.
US Food & Drug Administration
University of Texas Health Science Center at Houston
[+1]
适应症
非糜烂性反流病
胃食管反流
胃肠道疾病
[+32]
靶点
Proton pump
CGA
药物
富马酸伏诺拉生
利匹韦林
VP-20621
[+4]
标准版
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