The FDA stamped approvals on three diabetes drugs containing the active ingredient in Takeda Pharmaceutical's Nesina. The drug is another in a class of meds known as DPP-4 inhibitors, which includes Merck's blockbuster Januvia, yet the approvals give Takeda new meds to sell after losing patent exclusivity to its blockbuster diabetes drug Actos last year.
The three newly FDA-approved drugs include Nesina or alogliptin, Kazano, which includes Nesina and metformin hydrochloride, and Osenia, a combination of Nesina with the active ingredient in Actos.
After delaying approval of Nesina at least twice since 2009, U.S. regulators have cleared the drug for use in adults with Type II diabetes, which afflicts about 24 million Americans and can lead to heart problems, blindness and damage to other organs. The agency conditioned the approval on Takeda doing 5 post-marketing trials on Nesina, including a cardio outcomes study. And that doesn't include the additional work for Kazano and Osenia, which comes with a boxed warning because of heart problems associated with Actos.
The FDA takes a firm--some industry folks would argue unreasonably so--stance on the safety of drugs for diabetes because of a history of heart problems associated with treatments for the disease.
"Controlling blood sugar levels is very important in the overall treatment and care of diabetes," said Dr. Mary Parks, director of the Division of Metabolism and Endocrinology Products in the FDA's Center for Drug Evaluation and Research, in a statement. "Alogliptin helps stimulate the release of insulin after a meal, which leads to better blood sugar control."
Takeda developed Nesina, which is approved in Japan, in partnership with Furiex Pharmaceuticals ($FURX). Furiex is in line to get payments related to approvals and sales of the drug.
Nesina faces fierce competition from a number of DPP-4 inhibitors already on the market, led by Merck's ($MRK) Januvia and including meds such as Onglyza from Bristol-Myers Squibb ($BMY) and AstraZeneca ($AZN) and Galvus from Novartis ($NVS).
- here's the FDA's release
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