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
Ref: PRNewswire | Image: The Straits Times
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