The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) issued positive opinions in September 2026 for two treatments targeting refractory inflammatory conditions. Povorcitinib (Povofortay, Incyte) received initial marketing authorization as the first oral therapy for adults with active moderate-to-severe hidradenitis suppurativa (HS) who have failed, are intolerant of, or have a contraindication to anti-TNF therapy. Secukinumab (Cosentyx, Novartis) received a label extension for adults with polymyalgia rheumatica (PMR) who respond inadequately to glucocorticoids or relapse during tapering.

Hidradenitis suppurativa is a painful, chronic skin condition causing nodules, abscesses, and scarring. Until now, approved treatments were limited to injectable biologics. Povorcitinib, a JAK1 inhibitor available as 45-mg and 75-mg tablets, demonstrated meaningful skin clearance and pain relief versus placebo, with responses emerging as early as week 3. For PMR — a common inflammatory condition marked by shoulder and hip pain and stiffness — secukinumab offered a meaningful steroid-sparing benefit over a 52-week period.

By the Numbers:

• STOP-HS1 & STOP-HS2 enrolled 1,227 adults; HiSCR50 at week 12: ~40–42% (povorcitinib) vs ~29–30% (placebo)
• ~1/4 to 1/3 of patients achieved high-threshold responses (HiSCR90/100) by week 54
• PMR trial (n=381): sustained remission at week 52 was 41.2% (secukinumab 300 mg) and 40.6% (150 mg) vs 20.4% (placebo)
• Secukinumab reduced mean annual cumulative prednisone dose to ~1,600–1,683 mg vs 2,093 mg with placebo

Why it matters: These approvals expand treatment options for two conditions with high unmet need — offering patients an oral alternative to injections for HS and a meaningful steroid-sparing strategy for PMR, both of which significantly impact quality of life.