Nesina alogliptin regulatory update

FDA’s Endocrinologic and Metabolic Drugs Advisory Committee recommended that the agency add language about potential risks of heart failure to the labels of 2 dipeptidyl peptidase-4 ( DPP-4; CD26) inhibitors to treat diabetes -- Onglyza saxagliptin from AstraZeneca plc (LSE:AZN; NYSE:AZN, London, U.K.) and Nesina alogliptin from Takeda. The recommendations came after the panel analyzed the data from 2 CV outcomes trials, SAVOR for Onglyza and EXAMINE for Nesina.

In both trials, the drugs met the primary endpoint of showing no increased risk of major adverse cardiovascular events (MACE). However, patients treated with Onglyza had a statistically significant 27% increase in hospitalization for heart failure in SAVOR. Patients taking Nesina had an increase of 19% in EXAMINE; the change was not statistically significant. Heart failure was not a component of the MACE endpoint. ...