Takeda’s Successor Drug to Actos Fails to Win FDA Approval

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Takeda’s Successor Drug to Actos Fails to Win FDA Approval

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Takeda Pharmaceutical Co. is Asia’s largest drug manufacturer and the maker of diabetes drugs. Takeda failed to win clearance to sell its new diabetes drug alogliptin in the United States. FDA regulators are asking for more information on the use of alogliptin in other countries.

The Food and Drug Administration requested information through a letter to Takeda. The company responded by stating that the necessary data can be supplied from information already being collected from patient studies outside the United States.

Alogliptin is has been approved in Japan and is sold by the name of Nesina. Takeda first applied to the FDA in December 2007 for approval to sell alogliptin in the US market. In June 2009, the FDA informed Takeda that its clinical data for alogliptin was insufficient based on new guidelines on diabetes treatments and cardiovascular risks. Takeda conducted additional studies for alogliptin and resubmitted for US sales. Following this latest failure to win approval, Takeda has said they are committed to bringing alogliptin to the US market. They will meet with the FDA determine the next steps needed to successfully win approval.

Alogliptin would be used to treat type-2 diabetes. Takeda’s other diabetes drug, Actos®, has been a top revenue generator. Actos® treats diabetes by helping the body make better use of the insulin and preventing the liver from making excess sugar. Actos® loses patent protection in four months.

In 2010, the FDA conducted a study that showed an increased risk of bladder cancer with the use of Actos® for more than 12 months. In mid-2011, the FDA issued an Actos® bladder cancer safety announcement. The announcement stated that the use of Actos® for more than one year may be associated with an increased risk of bladder cancer. Anyone taking Actos® for more than one year may face up to a 40% increase in the risk of developing bladder cancer. The safety announcement required that this information be added to the drug’s warning label.

If you or a loved one has developed bladder cancer from the use of Actos®, you may qualify for compensation to help with the cost of your medical expenses and pain and suffering. To contact an Actos® lawyer for a free consultation and Actos® lawsuit information, call Longo Legal, PLLC at (855) 566-4648.

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