A Food and Drug Administration (FDA) advisory panel has voted to recommend the approval of a new type of type 2 diabetes medication two years after it was rejected by regulators based on concerns that it could increase the risk of cancer and cardiovascular events.
Dapagliflozin, from Bristol-Myers Squibb and AstraZeneca, is a once-daily pill in a new class of diabetes medications known as SGLT-2 inhibitors. The FDA rejected the drug in January 2012, saying it needed more data to asses breast and bladder cancer concerns as well as heart risks. The drug companies resubmitted the application with several new studies and additional long-term data extending up to four years. The FDA agreed to reconsider the medication with a goal of voting on whether to approve it by January 11, 2014.
The FDA is not required to follow the recommendation of its advisory panel, but it usually does. Other strong factors that suggest dapagliflozin will likely be approved by U.S. drug regulators is that it is already in use in Europe, where it is sold under the name Forxiga. It is also sold in Australia, Brazil, Mexico and New Zealand.
Type 2 diabets drugs have come under closer review in recent years since the blockbuster medication Avandia was severely restricted in 2010 based on studies that showed the drug increased the risk of fatal heart attacks. The FDA recently lifted some of the restrictions on Avandia, but said there was still some “uncertainty” about the drug’s cardiovascular safety.
A year later, the FDA warned that the widely prescribed Actos could put users at an increased risk of bladder cancer. That warning was followed by more studies that showed the diabetes drugs Januvia and Byetta were associated with acute pancreatitis and pancreatic cancer.