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

April 7, 2021 Auto Bot FDA, Moderate, regulatory, Review, Severe, sNDA, Treat 0

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

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