Merck & Co has chosen Japan to submit its first marketing application for once-weekly diabetes therapy omarigliptin.
The company said the filing for the DPP-4 inhibitor was based on a Japanese phase III study reported at the European Association for the Study of Diabetes (EASD) conference in the summer which showed the drug was comparable to Merck’s $4bn-a-year, once-daily DPP-4 inhibitor Januvia (sitagliptin) in controlling blood glucose levels in type 2 diabetes, with similar side effects.
Merck – known as MSD outside the US and Canada – is making quite a considerable investment in omarigliptin with nine phase III trials involving around 7,500 patients around the world and filings in the US and Europe due in the coming months.
The company hopes the once-weekly drug will make in-roads in a market in which all other DPP-4 inhibitors require daily dosing, improving patient convenience and compliance, particularly as diabetics sometimes have to take multiple tablets per day.
Ira Gantz from Merck Research Laboratories told the EASD meeting in September that omarigliptin “has the potential to improve patient adherence, which might translate into better glycaemic control and disease outcomes”.
Analysts at Datamonitor question the value of weekly DPP-4 inhibitors, however, pointing out that many people with diabetes require treatment with metformin as well and only around 4% are prescribed a DPP-4 inhibitor on its own.
This means that the greatest demand will be for combinations of DPP-4 inhibitor with metformin in the same tablet, and potentially a DPP-4 inhibitor alongside an SGLT-2 inhibitor such as Johnson & Johnson’s Invokana (canagliflozin) and Bristol-Myers Squibb’s Forxiga/Farxiga (dapagliflozin).
Trailing Takeda in Japan
Merck is not however the first company to file for approval of a once-weekly DPP-4 inhibitor in Japan, which has around six million adults with type 2 diabetes.
US biopharma company Furiex is also developing a once-weekly DPP-4 inhibitor called trelagliptin (SYR-472) that has been licensed to Takeda and was filed for approval in Japan in March. If approved, trelagliptin could be on the market in the first half of next year, with Furiex eligible for royalties and sales-based milestone payments.
Phase III data for trelagliptin – also reported at this year’s EASD meeting – showed its ability to control blood glucose levels over 24 weeks was comparable to Takeda’s once-daily DPP-4 inhibitor Vipidia/Nesina (alogliptin).