AstraZeneca encouraged by Onglyza recommendations

AstraZeneca is “encouraged” by recent recommendations for Onglyza to treat adults with type two diabetes.

The Food and Drug Administration’s (FDA’s) Endocrinologic and Metabolic Drugs Advisory Committee agreed the supporting data for the drug application sufficiently ruled out certain risks relative to comparators in the programme.

Bristol-Myers Squibb is working with AstraZeneca on the remedy and now the body has unanimously suggested both firms work on a post-marketing trial to verify the cardiovascular profile of Onglyza.

A series of phase IIIb and IV studies are now underway to further characterise the long-term clinical effectiveness of the treatment and the companies will liaise with the FDA to finalise the design.

Chief medical officer of AstraZeneca Howard Hutchinson said he looks forward to ongoing discussions and is positive about the recommendations.

He concluded both firms are “committed to delivering options that offer real benefits to patients and healthcare providers”.

On June 9th and 10th, the FDA’s Psychopharmacologic Drugs Advisory Committee will meet to discuss the safety and efficacy of AstraZeneca’s Seroquel drug application for the treatment of schizophrenia in adolescents and bipolar mania in ten to 17-year-olds.