This news from the FDA followed a resubmission after the FDA’s complete response letter for the P2X3 receptor antagonist’s use in refractory chronic cough and unexplained cough.
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AbbVie drug Skyrizi is now approved for Crohn’s disease, making it the first treatment for the disorder that addresses a particular protein associated with inflammation. In other drug decision news, the Rhythm Pharmaceuticals product Imcivree added the rare disease Bardet-Beidl syndrome as a new approved indication.
- Third approved indication for SKYRIZI (risankizumab-rzaa) is supported by safety and efficacy data from two induction and one maintenance clinical trials.
The approval is the third indication for the anti-interleukin 23 monoclonal antibody after approval for psoriatic arthritis earlier this year and plaque psoriasis in 2019.