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Boehringer and Lilly’s type 2 diabetes drug Synjardy gets European marketing authorization

Boehringer Ingelheim and Eli Lilly have received marketing authorization from the European Commission (EC) for Synjardy, a new single-pill combination therapy, to treat adults with type 2 diabetes (T2D) in the European Union (EU).

Synjardy is a combination of empagliflozin, a sodium glucose cotransporter 2 (SGLT2) inhibitor, and metformin hydrochloride (HCl), commonly prescribed to treat T2D.

In the EU, empagliflozin was approved in May 2014 and is available in many countries as an oral, once-daily tablet, marketed as Jardiance.

The marketing authorization is based on data from seven Phase III clinical trials evaluating the safety and efficacy of empagliflozin as add-on to metformin either alone or in combination with other blood glucose-lowering drugs (pioglitazone, sulphonylurea, DPP-4 inhibitors and insulin).

These trials involved more than 7,000 patients with T2D, of which over 4,700 were treated with empagliflozin as add-on to metformin.

Synjardy is indicated for use alongside diet and exercise to improve blood glucose control in adults with T2D when they are inadequately controlled on their maximally tolerated dose of metformin alone.

The drug is used in patients who are inadequately controlled with metformin in combination with other glucose-lowering medicinal products, including insulin as well as for those who are already being treated with the combination of empagliflozin and metformin as separate tablets.

Boehringer Ingelheim chief medical officer professor Klaus Dugi said: "A single medicine is often not sufficient for patients to maintain blood glucose control in the long term, resulting in the need for combinations of blood glucose-lowering drugs.

"We are delighted to offer this single-pill combination of two agents with different mechanisms. Synjardy may help adults with T2D achieve their blood glucose targets with the added benefit of a convenient treatment regimen."

The EC marketing authorization follows the positive opinion from the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) in March 2015.