One of the best selling diabetes drug Onglyza may increase death rate as per a new FDA report which was posted on the agency’s website on Friday. It comes just ahead of an April 14 meeting of an FDA advisory panel which is scheduled to deliberate on the drug’s safety. Onglyza was approved in 2009.
FDA had issued guidelines requiring drug companies to conduct studies to confirm that the new diabetes drugs do not increase cardiovascular risks in comparison to current treatments. The new guidelines were put into place after growing concerns about the safety profile of many diabetes drugs.
It was revealed in a company sponsored trial of more than 16,000 patients known as SAVOR earlier that patients taking Onglyza also known as saxagliptin, had an increased risk of hospitalization due to heart failure.
FDA found that heart failure risk was valid. It also identified a possible elevated risk of death from all causes. Though the overall trial results did not show increased death risk, a detailed analysis of patients who took the drug suggests “a significantly increased risk of all-cause mortality,” the review found.
The FDA however did mention that the deaths were often “multifactorial” and many patients could be suffering from serious medical conditions in the days and weeks prior to death.
Still, the FDA said it “is not reassured” by the increased risk, “and we do not necessarily view this pattern of variable causes as evidence the mortality signal is due to chance.”
The news led to a steep fall in AstraZeneca shares in London by more than 2%. The drug sold worth $820 million last year and the commercial risks of the latest missive by FDA is enormous.
Analysts opine that FDA’s concerns over all-cause mortality were unexpected and it could lead to cuts in the peak annual sales estimate especially if Merck & Co’s rival drug Januvia does not show similar problems.