Approval of diabetes drugs from AstraZeneca/B-MS and Novo Nordisk supported by EU's CHMP; Faslodex cleared in Japan

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive recommendation for the marketing authorization of Anglo-Swedish drug major AstraZeneca (LSE: AZN) and US partner Bristol-Myers Squibb’s (NYSE: BMY) Komboglyze (saxagliptin [also known as Onglyza] and metformin HCl immediate-release fixed dose combination) as an adjunct to diet and exercise for the treatment of type 2 diabetes in adults who are not adequately controlled on metformin or those already being treated with the combination of saxagliptin and metformin as separate tablets.

The positive opinion was reached after the CHMP reviewed data from a Phase III clinical program that involved 4,326 patients with type 2 diabetes, including 2,158 individuals receiving saxagliptin plus metformin. The advisory panel’s positive opinion on Komboglyze will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union. The US Food and Drug Administration approved the combination drug last year (The Pharma Letter November 8).

Positive opinion on the use of Levemir in children with type 1 diabetes