AstraZeneca/B-MS’ DPP-4 inhibitor Onglyza approved by FDA

AstraZeneca and Bristol-Myers Squibb have been given the go-ahead by regulators in the USA to sell their diabetes drug Onglyza.

The US Food and Drug Administration has approved Onglyza (saxagliptin), a once-daily tablet which belongs to the dipeptidyl peptidase-4 (DPP-4) inhibitor class of type 2 diabetes treatments. The agency, which noted that the green light was based on data from eight clinical trials, noted that the most common side effects observed with Onglyza are upper respiratory tract and urinary tract infections, plus headaches and allergic-like reactions such as rash and hives.

The FDA also noted that the application for approval was submitted before December 2008 when the agency recommended that manufacturers of new diabetes drugs “carefully design and evaluate their clinical trials for cardiovascular safety”. Although Onglyza was not associated with an increased in patients who were mainly at low risk for such events, the FDA has told AstraZeneca and B-MS they have to conduct a postmarket study “that will specifically evaluate cardiovascular safety in a higher risk population”.

The approval comes as no great surprise seeing as the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee recommended Onglyza in April, deciding by a vote of 10 to 2 that the data supporting the New Drug Application for saxagliptin were sufficient to rule out “unacceptable cardiovascular risk relative to comparators in the programme”. European regulators backed approval of the drug last month.

If approved, the drug will compete with Merck & Co's big-earning DPP-4 inhibitor Januvia (sitagliptin), which is well-established on the market. Nevertheless, analysts believe there is a place for Onglyza and predict that the product will be a blockbuster.