WASHINGTON: The landscape of type 2 diabetes treatment changed dramatically this week when Merck & Co. received approval by the Food and Drug Administration for its Janumet tablet.
GCI Group has provided communications assistance on the product since May 2006. Merck now expects the pills to be available in a matter of weeks, according to Lesley Reid, coordinator for US human health public affairs at Merck.
Janumet is a two-in-one tablet containing a Merck drug, Januvia, and an older drug, metformin. Januvia was approved last October by the FDA, with GCI also providing assistance on that product. Reid confirmed that GCI would continue to work on the marketing of Janumet, and the company will likely highlight its convenience for patients, some of whom are already taking Januvia and metformin simultaneously.
"The key benefit of Janumet is that it delivers powerful efficacy in a single tablet with weight loss comparable to metformin alone and no increased risk of hypoglycemia (when blood sugar drops too low) beyond metformin alone," explained Reid, via e-mail. "In addition to that, it is convenient with one single tablet and one co-pay."
The US Centers for Disease Control estimates that about 20 million Americans have diabetes - and up to 90% of those individuals suffer from type 2 diabetes. That staggering figure means new treatments for the disease have significant blockbuster potential.
The approval comes at a particularly important time for Merck, with the race to provide improved, effective, and convenient treatment for type 2 diabetes reaching a critical point.
Merck's main rival, Novartis, had its new drug application for Galvus accepted for standard review by the FDA on March 30.
Fleishman-Hillard is assisting Novartis on the Galvus launch.
Both Galvus and Janumet are DPP-4 inhibitors, targeting the pancreatic islet dysfunction that causes high blood sugar levels in people with type 2 diabetes.