The Food and Drug Administration has granted approval for
to begin selling a diabetes pill that combines generic metformin with the company's recently approved Januvia.
The new drug, called Janumet, helps Merck stretch its lead over
, its closest competitor for a new class of drugs called DPP-4 inhibitors. Novartis' Galvus remains under regulatory review in the U.S. and the European Union.
Merck said Janumet will be "broadly available in pharmacies in the near future." Merck received
FDA approval for Januvia in October as a stand-alone treatment and as a treatment that could be used with two other types of medications to control blood sugar.
One of them is metformin. Merck will market Janumet as a greater convenience because many diabetics take more than one medication to control their blood-sugar levels.
The FDA'a approval of Janumet follows a decision by European Union regulators on March 26 to endorse Januvia. Merck has said it will begin selling Januvia shortly in 27 EU nations. The drug is available in 42 countries.
Many analysts see dipeptidyl peptidase-4 inhibitors as products that could achieve $1 billion or more in annual sales.
Januvia and Janumet are prescribed for people with type 2 diabetes, which accounts for at least 90% of the cases of the disease. Patients with type 2 diabetes don't produce enough natural insulin or they are unable to adequately process insulin. Type 1 diabetics, who don't produce insulin, can't use these drugs.
Like metformin, the Janumet label has a "black box" warning -- the FDA's strongest alert -- indicating that it can cause lactic acidosis, a rare but serious side effect caused by a buildup of lactic acid in the blood. Januvia doesn't cause this side effect.
Januvia is a once-a-day pill, while Janumet, like metformin, is taken twice a day.
In clinical trials, Januvia and Janumet have avoided the side effects that have slowed the regulatory approval of Novartis' DPP-4 inhibitor. The FDA told Novartis in February that it wanted
more clinical testing on Galvus' impact on patients with kidney problems. The drug won't reach the U.S. this year.
Last November, the agency told Novartis it was delaying a decision on Galvus so it could spend several months analyzing data that shows the drug produced skin lesions in monkeys. Novartis said the lesions didn't affect people who had been tested for as long as 24 months.