A new diabetes drug that helps the body control blood sugar won U.S. approval on Tuesday, making it the first in a new class of pills that treat the disease without the weight gain seen with some other drugs.
The Food and Drug Administration approved Merck & Co. Inc’s oral diabetes drug Januvia treat adults with type 2 diabetes, which affects the majority of the nearly 21 million Americans with the disease.
It occurs when the body builds resistance to insulin needed to break down food and causes blood sugar levels to be too high. Obesity is a major risk factor for the disease, which if not controlled can lead to heart problems, blindness and other complications.
Januvia, known generically as sitagliptin, can be used alone or along with other oral diabetes drugs such as metformin and PPAR agonists, the FDA said, adding that diet and exercise should also be part of the treatment.
“We now have another option that treats the disease in an entirely new way that can be added to existing treatment regimens to help patients gain more control over their blood sugar levels,” said Dr. Steven Galson, director of the FDA’s Center for Drug Evaluation and Research.
Some type 2 diabetes sufferers require insulin shots as part of their treatment but others rely on oral medicines.
Once-a-day Januvia is expected to face competition from Novartis AG’s rival medicine Galvus, which is awaiting FDA approval, possibly next month.
Both drugs are part of a new class of medicines called dipeptidyl peptidase IV, or DPP-4, inhibitors that work to enhance the body’s own ability to lower blood sugar. In clinical trials of the new drugs, patients did not gain weight.
The drugs will also compete with older diabetes medications known as thiazolidinediones, or TZDs, which make patients less resistant to insulin. Those drugs are used as add-on treatments and have been linked to water retention and weight gain.
“Despite the drugs that are out there, the vast majority of patients out there are not at (their) treatment goal,” Jay Galeota, head of Merck’s global diabetes franchise, told Reuters last week.
Analysts expect Januvia and Galvus could each generate more than $1 billion a year in sales, but it was not immediately clear how soon Merck would make its drug available for the growing number of patients with diabetes.
Whitehouse Station, New Jersey-based Merck said Januvia would be in pharmacies “in the near future” and would cost $4.86 per tablet. Januvia is already cleared in Mexico and is awaiting approval in other countries, Merck has said.
“If (Merck) can ship fairly quickly here, that month may be important, just to get their samples out first and get it into doctors’ hands first,” said Natexis Bleichroeder analyst Jon LeCroy, who projects $1.6 billion in Januvia sales in 2010.
A survey of about 60 physicians, conducted by Reuters Primary Research, shows the vast majority of doctors intend to start prescribing Januvia and Galvus right way.
Dr. Stuart Weiss, an New York University Medical Center endocrinologist, said the drug’s ability to control blood sugar spikes without added weight gain was a big draw.
“In the face of a diabetes epidemic, this drug … is particularly an inviting choice,” said Weiss, who has consulted for several Merck competitors, including Novartis.
Common side effects in patients studied were diarrhea, sore throat and upper respiratory tract infection, the FDA said.