Lilly, Boehringer bag FDA okay for diabetes triple Trijardy XR

Eli Lilly and Boehringer Ingelheim’s longstanding alliance in diabetes has delivered another new product, this time a three-drug combination – Trijardy XR – that extends their blockbuster Jardiance franchise.

The new product contains SGLT2 inhibitor empagliflozin, the active ingredient in Jardiance, along with DPP4 inhibitor linagliptin (sold as Tradjenta in the US) and generic diabetes drug metformin hydrochloride.

It adds to the Jardiance stable, which also includes two-drug combinations Glyxambi/Jentadueto (empagliflozin/linagliptin) and Synjardy (empagliflozin/metformin).

Privately-held Boehringer is expected to report more than $2 billion in sales from empagliflozin products in 2019, while Lilly said it made $677 million from the franchise in the first nine months of that year.

Trijardy XR is a once-daily therapy that fulfils a need for the “many adults living with type 2 diabetes who are already on…multiple medications [but] still struggle to keep their blood sugar under control,” according to a Lilly statement.

First launched in 2014, Jardiance is currently the top-selling SGLT2 inhibitor in the US with a market share estimated at around 50% and at 41% worldwide, although it’s under pressure from fast-growing rival Farxiga (dapagliflozin) from AstraZeneca.

AZ reported $1.1bn in sales for Farxiga in the first three months of 2019, up 13% and fuelled in part by a first-in-class FDA approval to reduce the chances of hospitalisations for heart failure in adults with type 2 diabetes and other cardiovascular risks.

It’s also under priority review at the FDA for a new heart failure indication in patients with and without type 2 diabetes that could open up a much larger eligible population for the drug. That aside, patent protection is due to expire in the US this year, and generics are likely to drag down the entire SGLT2 category.

Trijardy XR could provide some defence against that impact. According to Boehringer’s vice president of medical affairs for diabetes, Mohamed Eid, the product provides “a new once-daily option combining three well-established medicines.”

That includes “an extended-release version of metformin, the most commonly prescribed initial treatment for type 2 diabetes, Jardiance, the most prescribed SGLT2 inhibitor, and Tradjenta, the only single-dose DPP-4 inhibitor,” he added.

News of Trijardy XR’s approval comes just a few days after the FDA also granted a tentative marketing approval to the first generic version of Jardiance, developed by Alembic Pharmaceuticals.

Alembic still needs to resolve patent disputes before it can launch its product without risk of potentially costly litigation, while Lilly and Boehringer say Jardiance remains protected from generic competition by US patents until 2029.