Actos News

FDA's Surprising Approval of Diabetes Drug Nesina
Tuesday, February 5, 2013

Takeda Pharmaceuticals, the manufacturer of diabetes drug Actos (pioglitazone), saw sales of the drug plummet by over 50 percent at the end of last year. The dramatic drop in sales was mainly due to U.S. and European regulatory agencies issuing safety warnings linking Actos to an increased risk of bladder cancer. 

Now that the patent on Actos has expired, Takeda is apparently looking for other sources of revenue. Actos, once one of the most widely-prescribed drugs in the world, has been replaced by Nesina (alogliptin), and Takeda has high hopes for its success. Surprisingly, the U.S. Food and Drug Administration approved Nesina, along with combination drugs Kazano and Oseni, the latter of which contains pioglitazone. 

The approval of Nesina is surprising because the FDA had previously rejected the drug's initial application in 2008, citing concerns about heart attacks. The approval of Oseni, on the other hand, seems completely at odds with public safety after the agency issued many safety warnings regarding the link between pioglitazone and bladder cancer.

All three drugs will have the required warning labels but Kazano and Oseni will carry a black box warnings for lactic acidosis and heart failure respectively. Oseni’s labeling will also warn against the risk of bladder cancer and list it as a harmful side effect of the medication.

The FDA has requested five post-marketing studies on Nesina to determine cardiovascular outcomes and to test the risks of liver abnormalities and pancreatitis. Three of these studies are focused on testing the effect of the drug on pediatric patients.

According to Pharma Times, sales of Nesina in Japan are already up 151 percent, netting Takeda over 25 billion yen.