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FDA lengths review of Skyrizi for Crohn’s

By Brian Buntz | February 28, 2022

Boehringer Ingelheim/AbbVieAbbVie (NYSE:ABBV) has announced that the FDA will prolong the review period for Skyrizi (risankizumab-rzaa) to treat moderate to severe Crohn’s disease in patients 16 years and older.

The agency decided to extend the Prescription Drug User Fee Act (PDUFA) action date for the indication by three months to review additional data submitted from the sponsor related in part to an on-body injector.

FDA first approved Skyrizi, an interleukin-23 subunit p19 inhibitor, for moderate to severe plaque psoriasis in adults. Then, in January, it won an indication for adults with active psoriatic arthritis.

AbbVie developed the drug in partnership with Boehringer Ingelheim.

Last year, sales of the drug were $2.939 billion internationally.

AbbVie has also filed an application with the European Medicines Agency asking for approval of Skyrizi to treat patients at least 16 years with moderate to severe Crohn’s disease.

ABBV shares ticked down about 1% to $147.77.


Filed Under: Gastroenterology
Tagged With: AbbVie, Boehringer Ingelheim, plaque psoriasis, risankizumab-rzaa, Skyrizi
 

About The Author

Brian Buntz

As the pharma and biotech editor at WTWH Media, Brian has almost two decades of experience in B2B media, with a focus on healthcare and technology. While he has long maintained a keen interest in AI, more recently Brian has made making data analysis a central focus, and is exploring tools ranging from NLP and clustering to predictive analytics.

Throughout his 18-year tenure, Brian has covered an array of life science topics, including clinical trials, medical devices, and drug discovery and development. Prior to WTWH, he held the title of content director at Informa, where he focused on topics such as connected devices, cybersecurity, AI and Industry 4.0. A dedicated decade at UBM saw Brian providing in-depth coverage of the medical device sector. Engage with Brian on LinkedIn or drop him an email at bbuntz@wtwhmedia.com.

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