New Diabetes Drug that Includes Actos Rejected by FDA

The FDA has rejected approval of two new diabetes drugs developed by Takeda Pharmaceuticals, including a drug that contains a combination of a new treatment and Actos, a current diabetes drug that has been linked to a risk of bladder cancer. 

Takeda Pharmaceuticals announced in an April 25 press release that it had received a “complete response letter” from the FDA, indicating that the agency cannot approve use of the drug alogliptin and the combination drug of alogliptin and pioglitazone without more data on how the drugs have performed in other countries where they have already been approved. Pioglitazone is the active ingredient in Actos.

The drug maker is hoping that sales of the new diabetes treatment will replace the current sales generated by Actos, the company’s flagship diabetes drug, which is set to lose patent protection in about four months. That will open the market for generic versions of Actos, which will be cheaper than the brand-name drug.

In recent years, concerns have also emerged about a risk of bladder cancer from Actos, causing new warning information to be added to the medication label in the United States, Europe and Canada. As a result of the risk, regulators have removed Actos from the market in France and several critics have suggested that an Actos recall should be issued in the U.S. as well.

Takeda Pharmaceuticals currently faces a number of Actos lawsuits filed by individuals who allege that the drug maker failed to properly research the medication and attempted to conceal the risk of bladder cancer from consumers and the medical community.

The new proposed drugs are centered around alogliptin, a type-2 diabetes treatment which has already been approved in Japan under the brand name Nesina. It is a DPP-4 inhibitor, the same family of drugs as Januvia, Onglyza and Trajenta. Nesina is only alogliptin, while another proposed drug is a fixed-dose combination of Nesina and Actos.

Takeda Pharmaceuticals claims it can answer the FDA’s request for more data from the drug’s use in Japan and from ongoing clinical studies. But the company has been trying to get alogliptin on the U.S. market since it first applied for New Drug Approval (NDA) in 2007. The FDA rejected the NDA in June 2009, telling the company that it’s clinical data was insufficient for U.S. approval. Almost three years later, the agency appears to still be telling Takeda Pharmaceuticals the same thing.