CHMP recommended 12 medicines for EU marketing authorisation in September 2026.
The recommendations included medicines for haemophilia A, ALK-positive advanced non-small cell lung cancer, generalised myasthenia gravis, platinum-resistant ovarian cancer, hidradenitis suppurativa, short bowel syndrome and rabies prophylaxis.
Key decisions
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Povofortay was recommended for active moderate to severe hidradenitis suppurativa in adults; EMA describes it as the first daily oral treatment for patients refractory or intolerant to anti-TNF therapy.
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Pebrilzo, for breast cancer in adults, was the first biosimilar recommended following the tailored clinical approach.
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Two generics, Inijaq and Ruxolitinib Zentiva, also received positive opinions.
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CHMP recommended 11 indication extensions, including a lower age of use for Anzupgo to adolescents aged 12 years and older.
Two initial marketing-authorisation applications and three extension applications were withdrawn. Applicants requested re-examination of July negative opinions for Kemsu, Meplyffa and Qezzaqar. CHMP confirmed its refusal of Xervyteg after re-examination.
Read more at https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-14-17-september-2026
