Takeda Pharmaceutical Co is going to have to wait a bit longer to market alogliptin after US regulators said they need more time to evaluate the Japanese drugmaker’s experimental type 2 diabetes drug.
The US Food and Drug Administration notified the firm that it will not be able to complete a review of a New Drug Application of alogliptin, also known as SYR-322, by the Prescription Drug User Fee Act date of October 27. Alogliptin is a dipeptidyl peptidase IV (DPP-4) inhibitor and the NDA submission included data from six Phase III trials involving more than 2,000 patients.
The drug has been studied as a once-daily monotherapy adjunct to diet and exercise and as an add-on to other antidiabetic medications including sulfonylureas, metformin, thiazolidinediones, such as Takeda’s own Actos (pioglitazone) and insulin. The trials demonstrated that alogliptin was associated with statistically significant reductions in haemoglobin A1c and was generally well-tolerated and weight neutral. There was no increase in hypoglycaemia compared to placebo.
Speaking about the delay, Dean Sundberg, senior vice president, regulatory affairs at Takeda Global R&D Center in the USA, said the FDA has indicated that “due to internal resource constraints it will not be able to complete the alogliptin review by the PDUFA date”. He also noted the agency “did not provide Takeda with any guidance on when a review might be completed nor did it raise any issues with the data in the alogliptin NDA”.
Mr Sundberg concluded that Takeda remains confident in alogliptin’s potential “and we will work with the FDA as they continue this NDA review”.
Whatever the reason, the delay is not good news for Takeda as SYR-322 is seen as vital to the Osaka-based firm’s future success as it prepares for life after the blockbuster Actos, which loses patent protection in the USA in 2011. The FDA’s slowness is also a problem for the contract research organisation PPD, as the delay means it will not get a $25.0 million milestone payment just yet as it is dependent on the alogliptin NDA being approved.
