AstraZeneca and Bristol-Myers Squibb earn CHMP backing for Forxiga

AstraZeneca and Bristol-Myers Squibb have received a recommendation from Europe's Committee for Medicinal Products for Human Use (CHMP) for approval of their new diabetes drug Forxiga.

The European Medicines Agency committee has endorsed the dapagliflozin tablets therapy for type 2 diabetes, as an adjunct to diet and exercise and in combination with other glucose-lowering medicinal products, as well as for use as a monotherapy in metformin-intolerant patients.

It follows a CHMP review of data from a comprehensive clinical development programme that included 11 core phase III trials conducted among almost 5,700 patients.

The CHMP ruling will now be considered by the European Commission as it decides whether or not to grant final approval to Forxiga.

David Brennan, chief executive officer at AstraZeneca, said: "We are pleased the CHMP has given a positive assessment of the benefit/risk profile of this novel product in a new class for the treatment of type 2 diabetes."

This comes after the two partners received European approval for their collaboratively developed product Onglyza last year.