A label change for AstraZeneca’s DPP-4 inhibitor Onglyza (saxagliptin) could be on the horizon after the US Food and Drug Administration cited concerns that it could be linked with a higher risk of death.
Documents posted to the agency’s website - ahead of an endocrinologic and metabolic advisory committee meeting on April 14 - note that FDA sensitivity analysis of long-term data from the 16,000-plus-patient Savor trial suggest a potentially higher risk of all-cause mortality in patients taking AZ’ drug.
“Increases appeared across both cardiovascular and non-CV categories of deaths, and exploratory analyses to elucidate the etiology behind the all-cause mortality signal were unrevealing and did not shed light on a mechanism beyond treatment differences,” they said.
A review of outcomes data for Takeda's DPP-4 inhibitor Nesina (alogliptin) did not find a significantly increased risk of death, but if long-term data for Merck & Co's blockbuster Januvia (sitagliptin) - which should be revealed later this year - also ring warnings bells, it could have a significant impact on the entire class of drugs.
The Committee will discuss the data for Onglyza and Nesina at its meeting this week, and recommend if any action needs to be taken. But some industry observers already fear the worst. According to media reports, Leerink analyst Seamus Fernandez believes the FDA's “unexpected” concerns over all-cause mortality could take a 50% bite out of Onglyza’s forecast $1.8 billion peak annual sales, should others in the DPP-4 class come up clean.