(Reuters) – The U.S. Food and Drug Administration approved drugs from AbbVie Inc and Pfizer Inc for treating eczema, a skin disease, the companies said on Friday.
AbbVie’s Rinvoq and Pfizer’s Cibinqo have been approved to treat moderate-to-severe atopic dermatitis, or eczema, in patients who do not respond to previous treatment or when use of other treatments is not recommended.
Rinvoq’s approval was expanded from rheumatoid arthritis to treat eczema for patients 12 years and older, while Cibinqo was approved for use in only adults.
Both the drugs belong to a class called JAK inhibitors, which block inflammation-causing enzymes known as Janus kinases and target a range of autoimmune diseases.
Both Pfizer and AbbVie cited risks of serious infections and cardiovascular events, among others.
The expanded approval for Rinvoq follows significant delays amid concerns over safety of JAK inhibitors.
Cibinqo had last year received approvals from the European and UK regulators.
The FDA last month added its strictest warning to labels of JAK inhibitor drugs from Pfizer, Eli Lilly and AbbVie following a review of Pfizer’s Xeljanz, another JAK inhibitor.
The initial results from a trial showed an increased risk of serious heart-related problems and cancer in some patients being treated with the drug.
(Reporting by Leroy Leo in Bengaluru; Editing by Shailesh Kuber)