US drug major Merck & Co has won the first regulatory approval for Januvia, its new oral diabetes drug, in Mexico.
The green light is also the first for any drug in the dipeptidyl peptidase-IV inhibitor class, which work by enhancing the body’s own ability to lower blood glucose when it is elevated.
Januvia (sitagliptin phosphate) has also been filed for approval in the USA, Europe and other parts of the world, and Merck is expecting to hear from the US Food and Drug Administration (FDA) on its application by mid-October. It is running a few months ahead of rival DPP-IV inhibitor Galvus (vildagliptin) from Novartis, which should reach the market next year.
Meanwhile, GlaxoSmithKline and Bristol-Myers Squibb also have compounds in this class in Phase III clinical development, called Redona (denagliptin) and saxagliptin respectively. Also, Eli Lilly dropped out of an alliance with another candidate, Taisho’s TS-021, last week.