Eli Lilly and Boehringer Ingelheim have launched the first fixed-dose combination of two fast-growing diabetes drugs in the US.
The FDA approved Glyxambi – which combines the SGLT2 inhibitor empagliflozin with DPP-4 inhibitor linagliptin – in late January, allowing it to beat rivals from AstraZeneca (AZ), Johnson & Johnson/Tanabe and Pfizer/Merck & Co.
The combination is scheduled to be submitted for approval in Europe later this year, according to Lilly, which is banking on a new crop of drugs to help make up for the loss of revenues from generic competition to drugs like antidepressant Cymbalta (duloxetine) and Evista (raloxifene), which pegged back fourth-quarter revenues.
Speaking earlier this year, Lilly chief executive John Lechleiter noted that competition in the diabetes sector is fierce, with other established players such as Novo Nordisk, Sanofi and Merck “more formidable than ever” while other companies “have been attracted to the therapeutic areas in which we compete”.
Lilly is currently ranked at number four in the market, but has new products rolling out to market that will give it “a more complete range of medicines than any of our competitors, from oral drugs to insulins”, said Lechleiter.
Glyxambi is part of that, along with a fixed dose combination of empagliflozin and metformin and a biosimilar version of Sanofi’s Lantus (insulin glargine), although the company suffered a setback last month when its novel basal insulin – insulin peglispro – was delayed on safety concerns.
Interestingly, Glyxambi has been priced at around a 24% discount to the combined cost of parent products Tradjenta (linagliptin) and Jardiance (empagliflozin), in recognition of the need to encourage switching from single-agent therapy and drive uptake ahead of competitors reaching the market.
DPP-4 inhibitors are already widely used in diabetes and SGLT2 inhibitors are fast gaining ground, despite some initial concerns about safety.
There are suggestions 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.
The nearest rival is AZ’s dapagliflozin/saxagliptin combination, which is under regulatory review in the US.