The US FDA Extends Review Period of Olumiant’s sNDA to Treat Moderate to Severe Atopic Dermatitis

 The US FDA Extends Review Period of Olumiant’s sNDA to Treat Moderate to Severe Atopic Dermatitis

The US FDA Extends Review Period of Olumiant’s sNDA to Treat Moderate to Severe Atopic Dermatitis

Shots:

  • Lilly and Incyte reported that the US FDA has extended the review period of sNDA for baricitinib to treat adults with mod. to sev. atopic AD
  • The FDA has extended the action date, allowing the time to review additional data analyses submitted by Lilly in response to recent information requests from the FDA. The PDUFA date has been extended 3 mos. to early Q3’21
  • The companies are evaluating baricitinib in adult and pediatric patients with AD, AA, SLE, JIA, COVID-19 and also continues for RA

Click here to­ read full press release/ article | Ref: PRNewswire | Image: The Straits Times

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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