Boehringer Ingelheim and Eli Lilly have been given US approval for Synjardy, which combines the SGLT2 inhibitor empagliflozin with metformin.
The FDA approval for the combination therapy follows an EU green light in May and extends Boehringer and Lilly’s Jardiance (empagliflozin) franchise, allowing the two companies to compete on equal footing with rival SGLT2 inhibitors in the fiercely competitive diabetes market.
Johnson & Johnson’s Invokamet (canagliflozin plus metformin) and AstraZeneca’s Xigduo (dapagliflozin and metformin) already have marketing clearance in the US, getting the nod last year.
Synjardy has been approved by the US regulator as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes who are inadequately controlled by a regimen containing empagliflozin or metformin, or in patients currently receiving empagliflozin and metformin.
The rapid roll-out of combination therapies in diabetes is being driven by the recognition that tight glucose control is the key to avoiding the serious complications that occur once the disease has progressed, and simpler dosing regimens make that easier to achieve.
It is estimated that currently around half of all type 2 diabetes patients fail to achieve their blood sugar control targets, so there remains a need for new treatment options.
While their metformin combination lagged behind rivals, Boehringer and Lilly were the first to get approval in the US for a combination of an SGLT2 inhibitor with a DPP-4 inhibitor, a class which promises to become the dominant oral treatment for type 2 diabetes.
In March they secured FDA approval for Glyxambi, which places empagliflozin alongside the active ingredient in their DPP-4 inhibitor product Tradjenta (linagliptin), ahead of competition from AZ and J&J/Tanabe. A combination of Pfizer’s developmental SGLT2 inhibitor ertugliflozin with Merck & Co’s DPP-4 inhibitor Januvia (sitagliptin) is also in late-stage testing.
Synjardy is the fifth FDA-approved medicine to emerge from the Boehringer/Lilly diabetes alliance pipeline in the last four years, according to Paul Fonteyne, chief executive of Boehringer’s US unit.
A broad portfolio of drugs is needed because “no two people with diabetes are alike, and every experience is different,” he said.
Boehringer and Lilly started working together on diabetes in 2011 and restructured their alliance in certain markets last October.