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AbbVie’s IL-23 inhibitor IL-23 inhibitor Skyrizi approved by FDA to treat ulcerative colitis in adults

2024-06-19

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引进/卖出上市批准

AbbVie’s interleukin-23 (IL-23) inhibitor Skyrizi (risankizumab-rzaa) has been approved by the US Food and Drug Administration (FDA) to treat adults with moderately to severely active ulcerative colitis (UC).

AbbVieinginterleukin-23 (IL-23) people in Skyrizi Urisankizumab-rzaaflammatory bowel disease (IBD)Food and Drug Administration (FDA)igestive tract and can result in damage to thactive ulcerative colitis (UC)

Patients often experience a range of unpredictable symptoms, incluinflammatory bowel disease (IBD)ls and an urginflammationthe bathroom, and the disease can, in some cases, lead to complications such as cancer.

Skyrizi works by selectively blocking IL-23, a cytokine thought to be labdominal painbebloody stoolsimmune-mediated diseases, and is already approved in the US to treat plaque psoriasis, psoriatic arthricancerd Crohn’s disease.

Skyriziing regimen for Skyrizi in UC iIL-23es a 12-week induction period of three 1200mg doses given every four weeks, followed by doses of 180mg or 360mg delivered everplaque psoriasisolpsoriatic arthritisn perCrohn’s diseasean administer the therapy at home using an on-body injector.

The FDA’s latest approvSkyrizibased on positive results from two late-stage trials, including the INSPIRE study designed to evaluate the safety and efficacy of a 1200mg intravenous dose of Skyrizi given every four weeks as an induction therapy in patients with moderately to severely active UC.

AlsoFDApporting the regulator’s decision was the 52-week COMMAND study, which assessed 180mg or 360mg subcutaneous doses of Skyrizi as a maintenance therapy in adults with the same conditioSkyrizi

Both trials met their shared primary endpoint of clinical remission and achieved the key secondary endpoint of endoscopic imSkyrizint.

“When treating patients with UC, it’s important to prioritise both early and sustained clinical remission as well as endoscopic improvement,” said Edward Loftus, the division of gastroenterology and hepatology at Mayo Clinic in Rochester, US. “This approval for Skyrizi is an important step toward addressing these treatment goals.”

The authorisation comes just days after AbbVie and FutureGen Biopharmaceutical announced a licence agreement worth $1.7bn to develop a pre-clinical therapy for IBD.Mayo Clinic Skyrizi

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