FDA Approves AbbVie's Upadacitinib For Refractory Atopic Dermatitis In Patients 12 Years & Older

The FDA has approved AbbVie Inc's ABBV Rinvoq (upadacitinib) for atopic dermatitis in adults and children 12 years of age and older.

• The approval covers moderate to severe atopic dermatitis in patients whose disease did not respond to previous treatment, not well controlled with other pills or injections, or when the use of other pills or injections is not recommended.
• Related content: Benzinga's Full FDA Calendar.
• Rinvoq 15 mg once daily can be initiated in adults and children 12 years of age and older, weighing at least 40 kg. 
• In these children and adults less than 65 years who do not achieve an adequate response, the dose may be increased to 30 mg once daily.
• The FDA approval is supported by efficacy and safety data from Phase 3 programs in more than 2,500 patients.
• Across the three atopic dermatitis pivotal studies, Rinvoq monotherapy and with topical corticosteroids met all primary and secondary endpoints at week 16, with some patients achieving higher levels of skin clearance.
• Related: AbbVie, Lilly Atopic Dermatitis Treatments Hit With Further Delays With FDA
• AbbVie also confirmed prior revenue guidance of greater than $15 billion in combined Rinvoq and Skyrizi (risankizumab) risk-adjusted sales in 2025. 
• The company now expects 2025 risk-adjusted sales of greater than $7.5 billion for Rinvoq and greater than $7.5 billion for Skyrizi. 
• Price Action: ABBV shares closed lower by 1.76% at $135.87 on Friday.