FDA Gives Back To Back Approval To Pfizer's & AbbVie's JAK Inhibitors For Atopic Dermatitis

Along with AbbVie Inc's ABBV upadacitinib approval, the FDA approved Pfizer Inc's PFE oral daily JAK1 inhibitor Cibinqo (abrocitinib) to treat adults with moderate to severe atopic dermatitis.

• The approval covers patients who have not been able to get their disease under control with other medicines, including biologics, and those who can't take other treatments.
• The Friday approval covers Cibinqo in 100-mg and 200-mg doses, with the higher dose recommended for patients who don't respond to the 100 mg dose. 
• The agency also approved a 50-mg dose for patients with moderate kidney failure or certain other patients. 
• Related: Pfizer's Abrocitinib Beats Dupixent Late-stage Eczema Trial.
• The FDA approved the drug based on five clinical trials in more than 1,600 patients. Pfizer says its med showed improvements versus placebo across the trials in skin clearance, itch symptoms, plus extent and severity of the disease. 
• Cibinqo was originally set for an FDA decision last April, but the agency's safety examination of JAK inhibitors triggered a series of delays. 
• Price Action: PFE shares are down 1.18% at $54.30 during the premarket session on the last check Tuesday.