25 May 2012 | News | By BioSpectrum Bureau
EMA accepts market authorization plea for alogliptin
Singapore: The European Medicines Agency has accepted a marketing authorization application for alogliptin, a selective dipeptidyl peptidase IV, or DPP-4, inhibitor for the treatment of type 2 diabetes, by Takeda Global Research & Development Center.
Takeda Global Research & Development Centre is a subsidiary of Takeda Pharmaceutical, the largest pharmaceutical company in Japan.
"This is a critical milestone for Takeda as we continue investigating and expanding our therapeutic offerings for people with type 2 diabetes," said Dr Stuart Dollow, managing director, Takeda Global Research & Development Centre. "As type 2 diabetes is an increasing global issue, our commitment includes expanding across the globe to reach a wider patient population who could benefit from new treatments."
According to a press statement issued by Furiex, a drug discovery company, this acceptance triggers a $10 million milestone payment from Takeda to Furiex. Furiex receives royalty payments from Takeda for the sale of alogliptin products, trade names NESINA and LIOVEL, in Japan, and it will receive royalties on sales in Europe, if approved.
"The acceptance of the MAA submission for alogliptin is an important step in expanding this treatment option to a wider patient population," said Dr June Almenoff, president and chief medical officer of Furiex. The alogliptin submission is supported by robust clinical trials of alogliptin involving more than 11,000 patients treated for up to four years, and several ongoing studies.