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Eli Lilly and Incyte's Olumiant (baricitinib) Receives the US FDA's Breakthrough Therapy Designation for Alopecia Areata

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Eli Lilly and Incyte's Olumiant (baricitinib) Receives the US FDA's Breakthrough Therapy Designation for Alopecia Areata

Shots:

  • The FDA’s BT designation is based on P-II results of P-II/III BRAVE-AA1 study assessing baricitinib vs PBO in patients with AA
  • The P-II portion of the BRAVE-AA1 study demonstrated no new safety signals with no SAEs @36wks. Additionally- P-III portion of BRAVE-AA1 & P-III BRAVE-AA2 study- are currently evaluating baricitinib (2mg/4mg) vs PBO in patients with AA
  • Olumiant is an approved treatment for adults with moderately to severely active RA- approved in ~65+ countries- including the US- member states of the EU and Japan

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Ref: Eli Lilly | Image: Eli Lilly


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