- Drugmaker plans to file drug with the FDA by the end of year
- Pill could help Merck in highly competitive diabetes market
Merck & Co.’s experimental, once-a-week diabetes drug was as effective at regulating blood sugar as its top-selling daily pill Januvia, according to a study the company will submit to U.S. regulators this year as part of its effort to get the treatment approved.
In a study of 642 patients with type 2 diabetes, patients who took the once-a-week drug, omarigliptin, reduced their blood sugar to similar levels as those taking Januvia after 24 weeks. Blood sugar is a key measure of how well a patient’s diabetes is being controlled.
Other studies of omarigliptin, including a large trial to assess the drug’s effect on patients’ likelihood of having a heart attack or other cardiac event, are still ongoing.
For Merck, a successful once-a-week medicine could help the company fight back against competitors that are chipping away at the Kenilworth, New Jersey-based drugmaker’s dominance of the market for brand-name diabetes pills.
Last month, Eli Lilly & Co. and Boehringer Ingelheim GmbH’s pill Jardiance was shown to help prevent heart attacks, strokes and deaths from heart disease in high-risk patients. That result -- the first for any diabetes drug -- could threaten Januvia’s position as the pill of choice for patients who can’t get their diabetes under control with metformin, a cheap generic drug that’s usually the first step in therapy.
In a study earlier this year, Merck showed that Januvia didn’t increase patients’ heart risks when compared with a placebo.
"For some patients, a once-weekly is a nice option," Peter Stein, Merck’s vice president of diabetes and endocrinology research, said in an interview. "We wanted one that has the same efficacy and same safety profile as a once-daily."
Merck’s drugs belong to a class called DPP-4 inhibitors. The treatments help the body make more insulin, which helps remove sugar from the blood.
The rate of side effects in the trial were similar for both drugs, and included upper respiratory tract infections, diarrhea and back pain. One patient taking omarigliptin had their blood sugar fall to a dangerous level.
Merck is currently the biggest seller of pills in the $63 billion market for diabetes drugs. Januvia and a related drug, Janumet, together sold $6 billion last year, making up 14 percent of the company’s sales. Yet revenue from Januvia has been almost flat since 2012, even as the number of diabetics worldwide keeps rising. Meanwhile, competitors have introduced more than a half-dozen products since Januvia’s approval almost a decade ago.