AstraZeneca and Bristol-Myers Squibb have finally won the backing of advisers to the US Food and Drug Administration for their type 2 diabetes drug dapagliflozin.
The agency's Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 13-1 that the benefits of dapagliflozin, already marketed in Europe as Forxiga, outweigh "identified risks". The panel voted 10-4 that the data provided sufficient evidence that the sodium-glucose co-transporter 2 (SGLT2) inhibitor, relative to comparators, has an acceptable cardiovascular risk profile.
The vote is a welcome boost for AstraZeneca and B-MS, given that the FDA rejected the drug in January 2012 due to concerns about possible liver damage and the potential link with breast and bladder cancer. In response to the agency's complete response letter (CRL), a resubmission included several new studies and additional long-term data of up to four years’ duration, and AstraZeneca and B-MS have proposed post-market surveillance in an ongoing cardiovascular study for their drug.
If the FDA goes along with the panel, dapagliflozin will be the second SGLT2 inhibitor to hit the market after Johnson & Johnson's Invokana (canagliflozin), which was approved in March.
J&J Invokana combo setback
However J&J has suffered something of a setback after the FDA issued a CRL regarding a fixed-dose combination of Invokana and immediate-release metformin. The agency has requested additional information to support the comparability of the twice-daily dosing regimen of the combo and once-daily dosing of Invokana as a single agent.
J&J says it believes it can supply this information based on available clinical data from the Phase III programme that was carried out for Invokana.