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Home Industry News AstraZeneca expects final Onglyza decision soon

AstraZeneca expects final Onglyza decision soon

26th June 2009

AstraZeneca expects the European Commission to publish its decision on the marketing authorisation for Onglyza (saxagliptin) in the next few months.

The company is producing the drug with Bristol-Myers Squibb and it is intended to be an add-on therapy with metformin, a thiazolidinedione or a sulphonylurea for patients with type 2 diabetes.

A positive opinion of the therapy was met by the Committee for Medicinal Products for Human Use after it had reviewed data from a comprehensive clinical development programme, which involved 4,148 patients.

Saxagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor, noted AstraZeneca.

The company explained: “[It is] designed to enhance the body’s ability to decrease blood sugar (glucose) when it is elevated by acting on the natural hormones ? thereby increasing insulin production.”

As a result, the amount of glucose that is produced by the liver is reduced, it added.

The positive opinion will now be reviewed by the European Commission before it issues its final judgment on the medication.

Earlier this month, the Psychopharmacologic Drugs Advisory Committee conducted a review of AstraZeneca’s Seroquel (quetiapine fumarate) and found it to be safe and efficient as a schizophrenia treatment for adolescents.

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