Takeda--Nesina

Takeda appears in dire need of a reboot to its diabetes mainframe now that its top seller, Actos, has been subject to generics competition since August, contributing to further declines in sales of the fading blockbuster. In a key step, the Japanese drug giant has been working toward potential approvals of a DPP-4 inhibitor, Nesina, which is from its partner, Furiex Pharmaceuticals.

Though Nesina, or alogliptin, is approved in Japan, the FDA hit Takeda with a complete response letter for the therapy and a combo of the drug and Actos in April as the agency sought additional clinical data on the program. Takeda has since resubmitted its new drug application for the U.S. market, and the therapy is also under review in Europe.

While Takeda is following Merck and others with marketed DPP-4 inhibitors, the Osaka, Japan-based drugmaker is the first to reach late-stage trials with a GPR40 agonist for Type 2 diabetes. Discovered by Takeda, TAK-875 is a potential first-in-class drug that stimulates glucose-dependent insulin secretion. In February the company reported that the drug met the main endpoint of besting placebo in lowering A1C levels in a Phase II study without significantly increasing hypoglycemia.

Takeda and Furiex are also partnered on a long-acting DPP-4 inhibitor called trelagliptin, or SYR-472, which is in late-stage development in Japan, according to Takeda's midyear pipeline update. The candidate is taken once a week, rather than once a day like existing therapies in the class. This and other contenders in Takeda's pipeline could help rejuvenate the company's diabetes business as Actos sales fall.

For more:
Takeda rebuffed (again) in long quest for FDA drug OK
FDA delays review of key Takeda diabetes drug, Actos combo

Drug: Nesina (alogliptin)

Mechanism: DPP-4

Phase: III

Partner: Furiex Pharmaceuticals

Drug: TAK-875

Mechanism: GPR-40

Phase: III

Drug: Trelagliptin

Mechanism: DPP-4

Phase: III

Partner: Furiex Pharmaceuticals

 

 

Takeda--Nesina
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