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

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

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  • 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

  Ref: PRNewswire | Image: The Straits Times

Click here to­ read the full press release 

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