AstraZeneca's ($AZN) diabetes drug Onglyza is under the FDA's microscope. The agency said it would review possible heart risks associated with the medication, which is one of the cornerstone products in the U.K.-based drugmaker's diabetes business.
The FDA review follows a New England Journal of Medicine study that flagged an increase in heart failure hospitalizations among patients who used Onglyza (saxagliptin). The active ingredient is also part of a metformin combination drug, Kombiglyze.
AstraZeneca nabbed full control of Onglyza in its recent buyout of Bristol-Myers Squibb's ($BMY) share in their longstanding diabetes partnership. Over the past couple of years, in deals with Bristol-Myers, the U.K.-based drugmaker has staked more than $7.5 billion on growing its diabetes franchise, and Onglyza is key to its strategy.
The FDA has stepped up its scrutiny of diabetes drugs and their heart safety, a major concern since cardiovascular risks were associated with GlaxoSmithKline's ($GSK) Avandia, touching off a public controversy. After the Avandia brouhaha, FDA said it would set a higher heart-safety bar for approving new diabetes drugs. It since denied approval to Novo Nordisk's ($NVO) new diabetes treatment Tresiba, asking the Danish drugmaker for a new study of its cardiovascular safety.
The saxagliptin review is part of the agency's overall look at the heart risks associated with type 2 diabetes treatments, the FDA said in a statement. The agency also pointed out that the NEJM study didn't find an increase in deaths, heart attacks or strokes in Onglyza patients. AstraZeneca and its development partner, Bristol-Myers Squibb, are expected to submit the relevant trial data by next month. While it's reviewing that data, the FDA says doctors should continue prescribing the drug according to labeling recommendations.
Onglyza is a DPP-4 inhibitor, a class of drugs that also includes Merck's Januvia (sitagliptin), Eli Lilly and Boehringer Ingelheim's Tradjenta/Trajenta (linagliptin) and Takeda's Nesina (alogliptin). Januvia has dominated the class, but AstraZeneca has been stepping up its bid for Onglyza sales.
- get the announcement from the FDA