US FDA again delays action on Takeda's alogliptin diabetes drug

Japan’s largest drugmaker Takeda Pharmaceutical (TYO: 4502) says it has received a complete response letter from the US Food and Drug Administration regarding New Drug Applications (NDAs) for alogliptin and fixed-dose combination (FDC) alogliptin and pioglitazone (Actos). Takeda has previously received a CRL for the product and refilled its submission last year (The Pharma Letter July 27, 2011).

Takeda says it recently provided post-marketing data from outside the USA, and has been in discussion with the FDA. The FDA has requested additional data which Takeda believes it can supply to the agency from post-marketing data from outside the USA, as well as data from its ongoing clinical trial program.

"We will immediately request a meeting with the FDA to determine the appropriate next steps and are committed to addressing outstanding issues. We remain confident in the benefit that alogliptin will bring to patients with type 2 diabetes in the USA, if approved," said Thomas Harris, vice president, regulatory affairs, Takeda Global Research & Development Center, noting that "Takeda has built a strong foundation in and maintained a robust focus on diabetes over the past 20 years, and we will continue to invest in developing a diverse range of innovative products for the growing type 2 diabetes population."