AbbVie, Lilly Atopic Dermatitis Treatments Hit With Further Delays With FDA

  • AbbVie Inc ABBV and Eli Lilly And Co LLY will have to keep waiting for a chance for their JAK inhibitors in atopic dermatitis to see the market.
  • The companies separately said on Friday that the FDA again delayed decisions over their applications for Rinvoq (upadacitinib) and Olumiant (baricitinib) in moderate to severe atopic dermatitis. 
  • Neither provided an updated timeline for the agency's decision. 
  • Federal regulators are working through safety concerns shrouding Pfizer's JAK inhibitor Xeljanz after a post-marketing study earlier this year turned up risks for dangerous heart side effects and cancer.
  • Olumiant, Xeljanz, and Rinvoq already bear boxed warnings about serious infections, blood clots, and cancers. 
  • As Xeljanz was the first of the class to enter the market, the FDA required Pfizer to conduct a long-term post-marketing study on its product to evaluate those risks further.
  • Friday's FDA delay marks the second holdup for Eli LillyIncyte Corporation INCY and AbbVie's eczema medicines following an initial setback in April.  
  • Price Action: LLY stock +0.27% at $232.09, INCY stock -0.94% at $79.25, and ABBV shares +0.44% at $117.69 during the market session on the last check Friday.
  • Related content: Benzinga's Full FDA Calendar.
Market News and Data brought to you by Benzinga APIs
Comments
Loading...
Posted In: BiotechNewsHealth CareFDAGeneralatopic dermatitisBriefs
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!