Merck & Co. is preparing to submit an application to the FDA for its once-weekly diabetes pill, omarigliptin. Results from a recent clinical trial suggest that omarigliptin is as good at maintaining normal blood sugar levels as the company’s diabetes medication, Januvia.
The study consisted of 642 patients being treated for type 2 diabetes. After 24 weeks, patients who were given omarigliptin had similarly low blood glucose levels, when compared to trial participants taking Januvia daily.
Blood sugar levels are an important indicator of how well a patient’s diabetes is being managed. While these are promising results, further studies into the drug’s safety – including whether or not it raises an individual’s risk of heart attack – are still being completed.
The once-weekly medication could help Merck retain their share in the diabetes drug market. While Januvia has been a best-seller for the company, multiple other pharmaceutical developers are launching their own diabetes management medications.
In August of this year, a study was released which showed that Jardiance – a diabetes drug developed by Eli Lilly & Co. and Boehringer Ingelheim – was able to help reduce the number of deaths caused by heart attack and stroke, in patients considered to be high-risk. Jardiance is the first diabetes drug to be able to make that claim.
Though Merck is currently unable to make the same claim regarding Januvia, they were able to show that the drug didn’t increase the risk of heart disease, in a trial conducted earlier this year. Januvia is currently the drug most often prescribed to patients who are unresponsive to treatment with metformin.
Peter Stein, Merck’s vice president of diabetes and endocrinology research, said, “For some patients, a once-weekly is a nice option. We wanted one that has the same efficacy and same safety profile as a once-daily.”
Both Januvia and the newly-developed omarigliptin are classified at DPP-4 inhibitors, and they work to reduce blood glucose by inducing the body to synthesize more insulin. Side effects for both of Merck’s diabetes treatments included diarrhea, upper respiratory tract infections and back pain.
Merck is the current industry leader in sales of diabetes drugs; a $63 billion market. Last year, the company sold $6 billion worth of Januvia and its related drug, Janumet, which accounted for 14 percent of Merck’s total sales.
Despite steadily increasing numbers of people diagnosed with diabetes each year, sales of Januvia have plateaued since 2012. The drug received FDA approval almost 10 years ago, and the industry has seen the release of multiple new diabetes medications in that time.
- Merck’s Once-Weekly Diabetes Pill Is as Good as Januvia in Study – http://www.bloomberg.com/news/articles/2015-09-16/merck-s-once-weekly-diabetes-pill-is-as-good-as-januvia-in-study