Gefurulimab

The EMA's drug advisory panel backed a dozen new medicines for approval at its September meeting, including Novo's Frehemgo (denecimig) for haemophilia A, Incyte's Povofortay (povorcitinib) in severe hidradenitis suppurativa (HS) and two therapies for ovarian cancer.Among the more closely watched decisions announced Friday, the agency's Committee for Medicinal Products for Human Use (CHMP) recommended Frehemgo for the routine prophylaxis of bleeding episodes in patients with haemophilia A, regardless of inhibitor status. The decision was supported by findings from the FRONTIER programme, in which Frehemgo significantly reduced the annualised bleeding rate compared to prior clotting factor prophylaxis and on-demand treatment. The next-generation factor VIIIa mimetic bispecific antibody, previously known as Mim8, has also shown comparable effectiveness in children.The drug's dosing flexibility – it can be given once-monthly, once every two weeks, or once-weekly via single-use pre-filled pens – could be a possible key differentiator (see — KOL Views Q&A: Novo Nordisk’s denecimig may struggle to displace entrenched Hemlibra in haemophilia A). A similar application for Frehemgo is under review in the US.On Friday, Novo also received a positive CHMP opinion to expand use of Sogroya (somapacitan) to include children living with idiopathic short stature with persistent growth disturbance. The once-weekly, long-acting human growth hormone analogue is already authorised in the EU for the treatment of growth hormone deficiency in adults and in children ages 3 years and older.Povofortay nears first OKMeanwhile, the positive opinion for Povofortay moves Incyte's oral JAK1 inhibitor one step closer to securing its first approval. CHMP's decision covers the treatment of active moderate-to-severe HS in adults who have responded inadequately to, or who are intolerant or contraindicated to an anti-TNF therapy.The submission is supported by findings from the Phase III STOP-HS1 and STOP-HS2 studies, which both met their primary endpoints by demonstrating significant reductions in abscess and nodule count. Longer-term results presented at this year's American Academy of Dermatology (AAD) meeting showed that up to 57% of HS patients taking Povofortay achieved ≥75% reduction in inflammatory lesions after one year in the trials.A filing in this indication is also under review in the US, while Incyte is planning applications in vitiligo based on data released earlier this year. Pair of ovarian cancer drugsIn ovarian cancer, CHMP backed the approval of drugs with two different mechanisms of action: Corcept Therapeutics' selective glucocorticoid receptor modulator Lifyorli (relacorilant) and IMPACT Therapeutics' oral PARP1/2 inhibitor Sepalna (senaparib).Lifyorli's positive opinion is for use in combination with nab-paclitaxel to treat platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer. The drug, which was approved earlier this year in the US, is seen as an advancement in ovarian cancer treatment. Deanna Gerber, an assistant professor of obstetrics and gynaecology at Weill Cornell Medicine, previously told FirstWord that Lifyorli is "going to be the next big thing" in the field (see – KOL Views Q&A: Relacorilant set for early uptake in platinum-resistant ovarian cancer).The recommendation was based on clinical data including from the Phase III ROSELLA trial, in which patients given Lifyorli plus nab-paclitaxel achieved improved progression-free and overall survival compared to nab-paclitaxel alone, without an increase in adverse events.The EMA panel also endorsed Sepalna as a maintenance treatment for advanced epithelial ovarian, fallopian tube and primary peritoneal cancer. The decision was supported by findings from the Phase III FLAMES study, in which Sepalna reduced the risk of disease progression of death by 57% compared to placebo when used as first-line maintenance monotherapy in a broad patient population with advanced ovarian cancer.Sepalna is already approved in China in the ovarian cancer maintenance setting, while IMPACT recently out-licensed certain rights to the drug to Pharmanovia, including in the EU.Other new drugs recommended for approval at CHMP's latest meeting include Xcovery's Gevalka (ensartinib) for adults with ALK-positive advanced non–small-cell lung cancer, AstraZeneca's Klygefa (gefurulimab) for generalised myasthenia gravis, Sanofi's rabies vaccine VaxRabeo, and Zealand Pharma's Zeydovio (glepaglutide) for the treatment of short bowel syndrome.