On 18 September 2026, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) announced the outcomes of its September 2026 meeting, including positive opinions for new biopharmaceuticals and indication extensions for already approved medicines.
The new medicines recommended for approval by the CHMP include:
- AstraZeneca/Alexion’s Klygefa® (gefurulimab) for the treatment of adult patients with generalised myasthenia gravis. According to AstraZeneca, if approved, Klygefa will be the first and only dual-binding nanobody C5 inhibitor for this patient population; and
- Novo’s Frehemgo® (denecimig). Frehemgo is a next-generation factor VIIIa mimetic bispecific antibody for the prophylaxis of bleeding episodes in patients with haemophilia A. Novo expects to launch Frehemgo® in the first European countries in Q4/2026 and more widely across the EU starting in early 2027.
The CHMP’s September 2026 recommendations for extended indications include:
- Novartis’ Cosentyx® (secukinumab) for the treatment of polymyalgia rheumatica in adults who have had an inadequate response to glucocorticoids or who experience a relapse during glucocorticoid taper;
- AstraZeneca/Daiichi Sankyo’s Enhertu® (trastuzumab deruxtecan), as monotherapy for the adjuvant treatment of adult patients with resected HER2-positive breast cancer who have residual invasive disease after neoadjuvant taxane-based and HER2-targeted treatment;
- MSD’s Keytruda® (pembrolizumab) in combination with Astellas’ Padcev® (enfortumab vedotin), as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment, for the treatment of adults with resectable muscle invasive bladder cancer (MIBC), whether or not the patient is ineligible for cisplatin-containing chemotherapy;
- Roche’s Ocrevus® (ocrelizumab) for the treatment of paediatric patients aged 10 years and older with relapsing forms of multiple sclerosis (RMS); and
- Johnson & Johnson’s Tecvayli® (teclistamab), for treatment of adult patients with relapsed or refractory multiple myeloma, who have received at least one prior therapy,
The CHMP also recommended approval of two biosimilars at its September 2026 meeting, as reported separately here.