FDA reviewers highlight risks for AstraZeneca’s Onglyza

11 April 2015

According to a preliminary review of data by US Food and Drug Administration reviewers, Anglo-Swedish pharma major AstraZeneca’s (LSE: AZN) Onglyza (saxagliptin), a treatment for type 2 diabetes, may pose health risks.

Last year, the FDA requested clinical trial data from AstraZeneca to investigate a possible association between use of saxagliptin and heart failure (The Pharma Letter February 12, 2014).

The FDA's report on Friday comes ahead of an April 14 meeting of the Endocrinologic and Metabolic Drugs Advisory Committee to discuss the safety of Onglyza, and Nesina (alogliptin) and Oseni (alogliptin and pioglitazone), similar drugs from Japan’s Takeda Pharmaceutical. Onglyza gained US marketing approval in 2009 and Nesina in 2013. Sales of Onglyza increased by 119% to $820 million for full-year 2014.

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