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Janssen files diabetes drug canagliflozin for approval in Europe

Could be second SGLT2 inhibitor to hit the market if AZ-BMS’ rival Forxiga is approved

Janssen has submitted its new type 2 diabetes treatment canagliflozin to European regulators for approval.

The drug is an oral once-daily sodium glucose co-transporter 2 (SGLT2) inhibitor, a new class of diabetes drugs, and works by blocking the reabsorption of glucose by the kidney. This increases glucose excretion and lowers blood glucose levels.

In Europe, an AstraZeneca/Bristol-Myers Squibbs rival drug Forxiga (dapagliflozin) is set to be the first SGLT2 to come to market, following its CHMP recommendation. The European scientific advisors gave Forxiga a positive opinion in April, putting it on course for full European approval before the end of July.

But Janssen, which submitted canagliflozin to US regulators earlier this month, may have a chance to overtake it in the larger stateside market.

AZ/BMS' drug stumbled there earlier this year after the Food and Drug Administration (FDA) questioned Forxiga's safety and requested more clinical data, potentially adding a significant delay to its approval.

Submitting its drug to the European Medicines Agency (EMA) Janssen presented data from one of the largest randomised clinical studies in type 2 diabetes.

The phase III trial programme included nine multi-centre studies involving more than 10,000 patients and featured a dedicated cardiovascular study conducted in patients who have or are at high risk for developing cardiovascular disease.

“Janssen is confident in the value of the comprehensive clinical trial programme of canagliflozin supporting the MAA [marketing authorisation application] to the EMA. However, the company cannot speculate on the outcome of this regulatory procedure whilst it is on-going,” the company said in a statement.

Results from five of the canagliflozin clinical trials were presented earlier this month at the American Diabetes Association (ADA) meeting in Philadelphia.

These showed Janssen's drug demonstrated substantial and sustained glycaemic improvements and two of the stand out trials showcased canagliflozin's potential as a monotherapy, comparing it to the current standard treatments of Januvia and Sanofi's Amaryl (glimepiride).

The SGLT2 market is shaping up to be one of the next battle grounds for pharma in diabetes.

In addition to Janssen's canagliflozin and AZ/BMS' Forxiga, Boehringer Ingelheim is preparing to submit its SGLT2 empagliflozin to US and European regulators next year.

27th June 2012

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