Japan approves four products
Japan's Ministry of Health, Labor and Welfare (MHLW) approved four products earlier this week, including Ryzodeg insulin degludec/insulin aspart from Novo Nordisk A/S (CSE:NVO; NYSE:NVO) to treat Type I and II diabetes. Ryzodeg is Novo's second diabetes product to be approved in Japan in the past three months -- in late September, MHLW approved Tresiba insulin degludec. Ryzodeg is a combination of 70% of Tresiba and 30% of Novo Nordisk's NovoLog insulin aspart.
MHLW also approved Eliquis apixaban from Bristol-Myers Squibb Co. (NYSE:BMY) to prevent ischemic stroke and systemic embolism in patients with non-valvular atrial fibrillation; BMS and partner Pfizer Inc. (NYSE:PFE) said they plan to launch the drug in Japan in February. The Japanese agency approved Cimzia certolizumab pegol from Astellas Pharma Inc. (Tokyo:4503) to treat rheumatoid arthritis (RA) in adults who have had an inadequate response to conventional treatment. The Japanese approval triggers an undisclosed milestone payment from Astellas to partner UCB Group (Euronext:UCB) under a February deal to co-develop and co-commercialize Cimzia in Japan (see BioCentury Extra, Feb. 1). ...