The label restrictions are settled!

CompilationAspirin

On December 15, 2021, Eastern Time, the FDA approved AbbVie's Rinvoq for the treatment of psoriatic arthritis, and also approved Pfizer's Xeljanz for the treatment of active ankylosing spondylitis

The delayed approval of the application for the treatment of inflammatory diseases occurred after the FDA completed the safety risk review and labeling restrictions of oral JAK inhibitor drugs

The limitations of these labels are not surprising

The extra caution for JAK inhibitor drugs stems from a post-marketing study by Xeljanz

The approval of Rinvoq's new psoriatic arthritis is based on two phase III trials

Psoriatic arthritis and ankylosing spondylitis are relatively minor indications for JAK drugs

In contrast, atopic dermatitis is a major indication observed by industry analysts

For rheumatoid arthritis and psoriatic arthritis, Rinvoq is only used in a dose of 15 mg

But Porges is not sure whether AbbVie can obtain approval for the high-dose Rinvoq for the treatment of eczema

Reference source: AbbVie's Rinvoq, Pfizer's Xeljanz win new uses after extended reviews as JAK safety woes linger