AstraZeneca and Bristol-Myers Squibb receive CHMP backing for diabetes drug
29 September 2011 00:00 in Pharmaceutical Company Product News
AstraZeneca and Bristol-Myers Squibb have been granted a recommendation from Europe's Committee for Medicinal Products for Human Use (CHMP) for the diabetes drug Komboglyze.
The immediate-release fixed dose combination of saxagliptin and metformin HCl has been endorsed by the European Medicines Agency committee for authorisation as a type 2 diabetes treatment, alongside diet and exercise.
This decision was based on positive findings from a phase III clinical study programme involving 4,326 type 2 patients, around half of whom were trialled using Komboglyze.
A single-tablet therapy, Komboglyze is intended for use among adults who are not adequately controlled on metformin, or those who are already receiving saxagliptin and metformin therapy as separate tablets.
The European Commission will now decide whether or not to approve the drug for this specification in Europe, taking the CHMP's recommendation into account.
Earlier this week, AstraZeneca and Bristol-Myers Squibb reported positive data from a phase IIIb study showing the efficacy of their drug Onglyza against diabetes, when used alongside insulin.
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Story collated for Zenopa by the Adfero News Agency