Takeda Receives NDA Approval for Diabetes Treatment in Japan

PPD has confirmed that Takeda Pharmaceutical Company’s New Drug Application (NDA) for Nesina (alogliptin), a highly selective DPP-4 inhibitor for the treatment of type 2 diabetes, has been approved by the Japanese Ministry of Health, Labour and Welfare. The former’s compound partnering division collaborated with Takeda to develop this product.

PPD is entitled to a US$7.5 million milestone payment from Takeda upon approval of all regulatory and pricing matters in Japan. The approval of the NDA constitutes the regulatory approval that is required for the milestone payment. Upon pricing approval in Japan, the former will be entitled to receive the milestone payment.