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Boehringer/Lilly's Jardiance approved in US

But the FDA wants four post-marketing studies of the SGLT-2 diabetes drug
Boehringer Ingelheim Eli Lilly

The diabetes alliance between Boehringer Ingelheim and Eli Lilly has borne fruit for the third time in the US, with the approval of their once-daily type 2 diabetes pill Jardiance (empagliflozin).

The FDA will require the partners to carry out four post-marketing studies for the drug, including the completion of an ongoing cardiovascular outcomes trial and a paediatric safety and efficacy study.

The FDA's decision follows six weeks after Jardiance's European marketing authorisation, which althought not contingent on extra studies being run did require a risk-management plan to be put in place.

Christophe Arbet-Engels, vice president, metabolic-clinical development and medical affairs at Boehringer, said: “Many adults with type 2 diabetes still have difficulty controlling their blood sugar levels even with treatment. There is a critical need for new treatment options to help these patients.”

Jardiance's US approval was based on phase III studies showing it significantly reduced hemoglobin A1C (a measure of average blood glucose over the past two to three months) and fasting blood sugar after 24 weeks.

The drug was evaluated as both monotherapy and in combination with several other treatments, including metformin, sulfonylureas, insulin and pioglitazone. Although it is not approved for weight loss, modest reductions were seen in the trials, Boehringer noted.

Jardiance is the latest in a new class called SGLT-2 inhibitors, which work independently of insulin by blocking the re-absorption of glucose into the bloodstream, causing it to be removed via the urine.

This is an increasingly competitive market, with already approved SGLT-2 inhibitors including Johnson & Johnson's Invokana (canagliflozin) and AstraZeneca's Forxiga (dapagliflozin).

Both these products are also available as combination treatments with metformin in versions called Vokanamet (Invokana and metformin) and Xigduo (Forxiga and metformin).

The US and European approvals now give Boehringer and Lilly and a chance to catch up on their rivals and a combination of Jardiance and metformin is also in the works.

Around 382 million people worldwide are estimated to have type 1 or type 2 diabetes - the vast majority the latter - and this figure includes approximately 29 million Americans with the chronic condition.

Article by
Adam Hill

4th August 2014

From: Sales

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