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.

Posted In: atopic dermatitisBriefsBiotechNewsHealth CareFDAGeneral

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