艾伯维口服JAK1抑制剂Rinvoq获美国FDA批准首个胃肠病适应症!

AbbVie recently announced that the U.S. Food and Drug Administration (FDA) has approved a new indication for the treatment of moderately to severely active ulcerative colitis (UC) in adults with an inadequate response to or intolerance to one or more tumor necrosis factor (TNF) blockers. This approval marks Rinvoq’s first indication in the field of gastroenterology [1].

Ulcerative colitis is a chronic relapsing inflammatory disease with an unknown cause. Its pathogenesis may be related to immunology, genetics, and the interaction between the environment (intestinal flora) and the intestinal barrier (mucosal layer and mucosal immune system). The lesions are mostly limited to The clinical manifestations of colon mucosa and submucosa are recurrent diarrhea, mucus, pus and bloody stools, and abdominal pain, accompanied by systemic symptoms such as fever, fatigue, and weight loss. If not treated in time, the disease may become cancerous if not treated in time, causing huge psychological pressure and economic negative consequences for patients.

This approval is based on data support from 2 Phase 3 induction studies and 1 Phase 3 maintenance study. At Week 8 of treatment in the induction study (Rinvoq 45 mg) and Week 52 of treatment in the maintenance study (Rinvoq 15 mg and 30 mg), a significantly higher proportion of patients in the Rinvoq treatment group achieved the primary endpoint (clinical remission) and all secondary endpoints compared with the placebo group.

What were found in the experiment were cough, nausea, fever, and upper respiratory tract infection. Overall, the safety of Rinvoq is still very high. Finally, the editor of Medical Companion Travel hopes that patients who are currently using Rinvoq will not believe or spread rumors. There are currently many unreliable rumors on the Internet. Spectrum Information has conveyed wrong information to everyone. For example, increasing the dose of a drug can double the therapeutic effect, or reducing the dose of a drug can avoid side effects. These are without any basis. Only by following the doctor's instructions can the effect of the drug itself be maximized.

Original source: [1] RINVOQ® (upadacitinib) Receives FDA Approval for the Treatment of Adults with Moderately to Severely Active Ulcerative Colitis

Note: The above information comes from the Internet and is compiled and edited by Medical Companion Travel (please correct me if there are any errors or omissions). It is only to provide information on the latest drugs on the market in the world and help Chinese patients understand the latest international new drug trends. It is only for internal discussion among medical staff and does not serve as any basis for medication. For specific medication guidelines, please consult the attending physician.