Merck & Co 's Januvia wins approval in Mexico

Merck Sharp & Dohme says that its breakthrough, once-daily, type 2 diabetes pill, Januvia (sitagliptin), has been approved in Mexico. The agent is the first in a new class of drugs known as dipeptidyl peptidase-4 inhibitors which enhance the body's own ability to lower blood sugar (glucose) when it is elevated, a mechanism of action that is distinct from that of any currently-available glucose-lowering drugs.

The approval by the Ministry of Health in Mexico represents the first new class of oral medication for this patient population since 1999, and MSD expects the drug to be available in pharmacies across the country by September.

On the day the approval was announced, August 8, shares in MSD's parent, USA-based Merck & Co, rose $0.16 to $41 in afternoon trading on the New York Stock Exchange. The market reacted positively to the clearance ahead of the US Food and Drug Administration's action on Januvia's New Drug Application, which is expected by mid-October. Merck says it also plans other regulatory filings in various countries around the world.