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CHMP September 2026 meeting recommends new medicines for haemophilia A, lung and ovarian cancer, myasthenia gravis

🇦🇹 BASG · Thu 12 Nov 2026

Austria's BASG has published its summary of the CHMP's September 2026 meeting, listing seven therapeutic areas with positive opinions and four new medicines described in detail.

BASG, the Austrian medicines agency, published its monthly CHMP highlights on 12 November 2026. The summary says medicines for seven indications received a recommendation for marketing authorisation: haemophilia A, non-small cell lung cancer, generalised myasthenia gravis, ovarian cancer, hidradenitis suppurativa, rabies prophylaxis and short bowel syndrome.

Frehemgo (denecimig) was recommended for routine prophylaxis of bleeding episodes in haemophilia A, congenital factor VIII deficiency. The wording covers patients with and without FVIII inhibitors who have severe disease (FVIII below 1%) or moderate disease (FVIII at or above 1% and up to 5%) requiring prophylaxis. BASG describes it as a bispecific antibody that binds activated factors IX and X on platelet surfaces and mimics the function of the missing factor VIII.

Gevalka (ensartinib) received a positive opinion for adults with ALK-positive advanced NSCLC. This covers patients not previously treated with an ALK inhibitor and those previously treated with crizotinib. Klygefa (gefurulimab) was recommended as add-on to standard therapy for adults with anti-AChR antibody-positive generalised myasthenia gravis. BASG describes it as an immunosuppressive nanobody that targets and blocks complement protein C5.

Lifyorli (relacorilant) was recommended in combination with nab-paclitaxel for adults with platinum-resistant high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who have had one to three prior systemic regimens. It is described as a glucocorticoid receptor antagonist. The text supplied ends mid-sentence, so the products for hidradenitis suppurativa, rabies prophylaxis and short bowel syndrome are not named here, and the page does not cover extensions of indication or EPARs in the available portion.

What it means for your team

  • Regulatory teams tracking haemophilia A, ALK-positive NSCLC, gMG or platinum-resistant ovarian cancer should review the CHMP summaries of positive opinion for the four named products.
  • The products for hidradenitis suppurativa, rabies prophylaxis and short bowel syndrome are not identified in the available text; check the full BASG or EMA highlights.
  • Market-access teams should note the precise indication wording, including prior-treatment restrictions and combination use, as it will shape labels and positioning.

Official source: BASG ↗

Article written by VigiEye from the official source (BASG). AI-assisted; check the source before acting.

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