US top most health agency FDA has asked Takeda to conduct an additional clinical trial to rule out any adverse effects of alogliptin in relation to heart, that means Takeda needs to conduct a cardiovascular safety trial for alogliptin.
Type 2 diabetes or non insulin dependent diabetes mellitus (NIDDM) is a disorder that is characterized by high blood glucose in the context of insulin resistance and relative insulin deficiency.
It is known that certain anti diabetes drugs sometimes lead to severe heart ailments. And, alogliptin is a selective dipeptidyl peptidase IV (DPP-4) inhibitor which is to be used as an adjunct to diet and exercise for type 2 diabetes treatment.
Takeda Global Research and Development Center, Inc., a wholly owned United States (U.S.) subsidiary received a complete response letter from the U.S. Food and Drug Administration (FDA) regarding the Company’s New Drug Application (NDA) for alogliptin for the treatment of type 2 diabetes, in this month.
The FDA has asked Takeda to conduct an additional cardiovascular safety trial that satisfies the December 2008 FDA Guidance.
Alogliptin NDA was filed prior to the release of the December 2008 FDA Guidance titled, “Guidance for Industry: Diabetes Mellitus – Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes,” the Agency FDA did not believe that the amount of existing alogliptin clinical data was sufficient to meet certain statistical requirements outlined in that Guidance.
“Takeda will continue to promote key initiatives in order to realize sustained growth from a medium to long term perspective,” said Takeda President & CEO, Yasuchika Hasegawa, Takeda Pharmaceutical Company Limited (Takeda).
Source: Takeda Pharmaceutical Company Limited, Japan