This approval is the first in the world for a new class of oral drugs for type 2 diabetes, namely dipeptidyl peptidase-4 (DPP-4) inhibitors, which enhance the body’s own ability to lower blood sugar (glucose) when it is elevated. The mechanism of action of DPP-4 inhibitors is distinct from that of any currently available class of glucose-lowering agents.
Mexico is the first country in the world to grant regulatory approval to Januvia (sitagliptin phosphate).
Januvia (also known as MK-431) remains an investigational product in the US, where Merck’s new drug application (NDA) for Januvia has been accepted for standard review by the FDA., Merck expects the FDA to act on the NDA by mid-October and, in the meantime, is also moving forward with regulatory filings in various other countries around the world.
The Mexican approval is clearly good news for Merck, which has seen its stock revive considerably recently after the fallout of the Vioxx withdrawal in 2004, thanks largely to winning key legal battles and gaining approval for several new products. Once Januvia hits the market, it too should help contribute to the company’s renewed success.