Takeda Pharmaceutical Company is withdrawing its MAA for alogliptin and alogliptin/ACTOS for the treatment of type 2 diabetes to conduct a long-term clinical study for alogliptin. The company has revised the target timing of the MAAs to 2012.
Due to Takeda’s decision, PPD, the company involved in the development of the drug, does not expect to receive the $10 million MAA-acceptance milestone fee from Takeda this year.
Alogliptin was also submitted to the FDA for approval in December 2007 and to Ministry of Health, Labour and Welfare in Japan during September 2008. In March the FDA told Takeda that it would apply the new guidelines related to evaluating cardiovascular risk due to investigational antidiabetic therapies in its review of alogliptin; these guidelines were released in December 2008.
Additionally, the FDA also said that it believed that the amount of existing alogliptin clinical data was insufficient to meet certain statistical requirements in the new guidance. Alogliptin’s PDUFA date is June 26. No one was immediately available to discuss the U.S. and Japan filings.
Takeda anticipates that the MAA submissions will be made with a more robust dataset necessary to ensure its approval. The additional two-year study is to evaluate the efficacy and safety of alogliptin compared to glipizide when used in combination with metformin in almost 2,500 subjects with type 2 diabetes whose blood sugar level is inadequately controlled with metformin.
Alogliptin is an inhibitor of dipeptidyl peptidase IV, an enzyme that metabolizes the insulin-increasing hormones glucagon-like peptide 1 and glucose-dependent insulinotropic peptide.