Merck & Co will no longer file for approval of once-weekly diabetes drug omarigliptin in the US or Europe, even though it is already on the market in Japan.
The company said in a statement that the decision did not relate to any safety or efficacy issues with the DPP-4 inhibitor, which might suggest it is not confident that the market is prepared to pay a premium for a weekly compared to a once-daily drug such as Merck’s own Januvia (sitagliptin) product.
There are thought to be other issues with once-weekly administration of DPP-4 inhibitors. While they are intended to reduce the burden of taking pills by diabetics and improve compliance, patients can rarely benefit from drug-free days as those on DPP-4 inhibitors often also take metformin, which must be dosed every day.
Some clinicians argue that it is easier for patients to keep track of dosing two drugs side by side rather than mixing weekly and daily doses.
Merck said it had made the decision “for business reasons” to divert its investment into other late-stage projects and new approaches to diabetes control in early-stage development.
It is also plausible that it took the decision in light of the recently-published cardiovascular outcomes trial for Eli Lilly/Boehringer Ingelheim’s leading SGLT2 inhibitor Jardiance (empagliflozin) showing a reduction in all-cause mortality.
The compelling data is expected to boost take-up of the latter class and limit growth of DPP-4 inhibitors, particularly as Januvia failed to show a benefit on mortality in its own cardiovascular outcomes trial.
Januvia and companion drug Janumet (sitagliptin plus metformin) brought in revenues of just over $6bn last year, in line with 2014, and the once-buoyant growth of the franchise has been eroding over the last few years in the face of competition.
As recently as last September, Merck was suggesting it would file for approval of omarigliptin with the FDA before the end of 2015, shortly after getting approval for the drug in Japan under the Marizev brand name.
It was not the first weekly DPP-4 inhibitor to reach the market, however, having been pipped to the post in Japan by Takeda’s rival drug Zafatek (trelagliptin succinate), which was approved in March 2015.
Takeda previously announced that it would not pursue approval of trelagliptin in the US and Europe, suggesting that the costs associated with obtaining approval in these markets were prohibitive.