Eli Lilly and Boehringer Ingelheim have scored the first approval – in the US – for a once-daily diabetes therapy based on two widely used drug classes.
The FDA has given the go-ahead to Glyxambi – a drug that combines the SGLT2 inhibitor empagliflozin with DPP-4 inhibitor linagliptin into a single-fixed-dose tablet taken in the morning – as a treatment alongside diet and exercises for type 2 diabetes.
Lilly and Boehringer have won the race to market, ahead of combinations based on AstraZeneca’s Forxiga (dapagliflozin) and Onglyza (saxagliptin), Johnson & Johnson’s Invokana (canagliflozin) and Mitsubishi Tanabe’s teneligliptin, as well as Pfizer’s ertugliflozin and Merck & Co’s Januvia (sitagliptin).
AZ said previously it was planning to file its combination by the end of last year, while the others remain in late-stage clinical testing.
DPP-4 inhibitors are already widely used in diabetes and SGLT2 inhibitors are fast gaining ground, despite some initial concerns about safety, and it has been suggested that combinations of the two will eventually become a major component of the market for oral type 2 diabetes therapies thanks to their simpler dosing regimens that will reduce pill burden and improve compliance.
SGLT2 inhibitors remove glucose through the urine by blocking blood glucose re-absorption in the kidney, while DPP-4 inhibitors work by increasing hormones that stimulate the pancreas to produce more insulin and stimulate the liver to produce less glucose.
In trials, Glyxambi was found to be superior in reducing haemoglobin A1C – a market for blood glucose control over time – when compared with either empagliflozin or linagliptin alone on top of background therapy with metformin.
The fixed-dose combination was co-developed by Eli Lilly and Boehringer Ingelheim under the terms of their wide-ranging diabetes alliance, which was first drawn up in 2011 and restructured in certain markets last October.
“Half of people with type 2 diabetes do not achieve recommended blood sugar control, making new treatment options more important than ever,” said Mike Mason, vice president of Lilly’s diabetes unit in the US.
“The approval of Glyxambi gives US physicians and patients a first-in-class prescription medicine to help manage this condition.”