The European Medicines Agency's CHMP has recommended approvals for two new treatments targeting refractory inflammatory conditions. Incyte's Povofortay is recommended as the first oral option for moderate to severe hidradenitis suppurativa, supported by phase 3 trials showing significant lesion reduction. Novartis's Cosentyx is recommended for label expansion to treat polymyalgia rheumatica, offering a steroid-sparing alternative that doubled sustained remission rates in clinical trials.
EMA CHMP positive opinions
- ▪At its September 2026 meeting, the European Medicines Agency's Committee for Medicinal Products for Human Use adopted positive opinions recommending initial marketing authorization for Povofortay and a new indication for Cosentyx.
- ▪Detailed recommendations for Povofortay and Cosentyx will be published in the updated Summary of Product Characteristics on the European Medicines Agency website after the European Commission issues its final decisions.
Povofortay for hidradenitis suppurativa
- ▪Povofortay is designed as 45-mg and 75-mg film-coated tablets, offering the first oral treatment option for hidradenitis suppurativa, which is currently treated primarily with injectable biologics.
- ▪Incyte's Povofortay, an oral JAK1 inhibitor, received a positive opinion for treating active moderate to severe hidradenitis suppurativa in adults who are intolerant of, contraindicated for, or have responded inadequately to anti-TNF therapy.
- ▪The most common side effects associated with Povofortay include upper respiratory tract infections, folliculitis, urinary tract infections, hyperlipidemia, headache, acne, and increased blood creatine phosphokinase.
STOP-HS trial results
- ▪The positive opinion for Povofortay was supported by two phase 3 trials, STOP-HS1 and STOP-HS2, which enrolled 1,227 adults with moderate-to-severe, treatment-refractory hidradenitis suppurativa.
- ▪In the STOP-HS1 trial, 40% of patients on 45-mg povorcitinib and 41% on 75-mg povorcitinib achieved the primary endpoint of HiSCR50 at week 12, compared to 30% of patients on placebo.
Cosentyx for polymyalgia rheumatica
- ▪Cosentyx is already authorized in the European Union for several inflammatory conditions, including plaque psoriasis, hidradenitis suppurativa, psoriatic arthritis, axial spondyloarthritis, and forms of juvenile idiopathic arthritis.
- ▪Novartis's Cosentyx, a monoclonal antibody targeting interleukin-17A, received a positive opinion to extend its therapeutic indication to adults with polymyalgia rheumatica who respond inadequately to or relapse during glucocorticoid tapering.
PMR phase 3 trial
- ▪Patients treated with Cosentyx required a lower mean adjusted annual cumulative dose of glucocorticoids (1,600–1,683 mg) compared to those on placebo (2,093 mg).
- ▪A phase 3 trial of 381 adults with recently relapsed polymyalgia rheumatica supported the Cosentyx recommendation, evaluating 300-mg and 150-mg doses against placebo alongside a 24-week prednisone taper.
- ▪At week 52 of the polymyalgia rheumatica trial, sustained remission was achieved by 41.2% of patients on 300-mg Cosentyx and 40.6% on 150-mg Cosentyx, compared to 20.4% on placebo.
Story comments
Loading comments…