At its October 2024 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended granting marketing authorisation for Novo Nordisk’s Alhemo® (concizumab) for routine prophylaxis of bleeding in patients of 12 years of age or more with haemophilia A (with FVIII inhibitors) or haemophilia B (with FIX inhibitors), and Lindis Biotech’s Korjuny® (catumaxomab) for malignant ascites.
The committee also recommended extensions of indications for Sanofi’s Kevzara® (sarilumab) for the treatment of polymyalgia rheumatica (PMR) in adult patients who have had an inadequate response to corticosteroids or who experience a relapse during corticosteroid taper, and BeiGene’s Tevimbra® (tislelizumab) for certain patients with previously untreated oesophageal squamous cell carcinoma (OSCC) and certain patients with gastric or gastroesophageal junction (G/GEJ) adenocarcinoma.
Two ustekinumab biosimilars also received positive opinions at CHMP’s October 2024 meeting, as reported here.