An innovative diabetes drug that the FDA declined to approve in January 2011 has been endorsed by the European Medicines Agency (EMA).

Forxiga (dapagliflozin), co-developed by AstraZeneca (AZ) and Bristol Myers-Squibb (BMS), is the first drug to treat type 2 diabetes by promoting excretion of sugar by the kidneys.

Concern over liver toxicity and cancer risks led the FDA to request more data on the drug, but the EMA determined that its benefits outweigh its risks.

Forxiga inhibits a target in the kidney known as SGLT2, blocking the absorption of blood glucose and causing its excretion in urine.

BMS, who discovered dapagliflozin, partnered with AZ in 2007 to develop the drug – which, if approved, would be the first SGLT2 inhibitor to reach the market.

However, in 2011 the FDA declined to give the drug marketing approval, citing evidence of increased rates of breast and bladder cancer and liver toxicity.

The agency requested further clinical data “to allow for a better assessment of the benefit-risk profile,” including results from ongoing studies and perhaps from new clinical trials.

The EMA said the increasing prevalence of type 2 diabetes and the side-effects of some current therapies meant there was a need for new treatment options.

According to the agency, clinical trials have shown that Forxiga improves blood glucose control either alone or in combination with other diabetes drugs, and its effect is sustained up to 102 weeks.

However, it noted, the increased risk of bladder and breast cancer was of concern, “especially in the light of potentially long treatment periods and a possible widespread use”.

The EMA said it will maintain “close observation” of these risks, following a planned study of the drug’s cardiovascular side-effects. It requested that the companies carry out an epidemiological study of Forxiga.

BMS Chief Executive Lamberto Andreotti said: “We are pleased the CHMP has given a positive assessment of the benefit/risk profile of this novel product in a new class for the treatment of type 2 diabetes, an area of high unmet medical need.”

The EMA has opened a review of all orlistat-containing medicines to determine whether rare cases of liver injury have an impact on their benefit-risk profile and conditions of use.

Anti-obesity medicines, including centrally authorised medicines Xenical (orlistat 120mg) and Alli (orlistat 60mg), plus medication already, or in the process of being authorised, will be analysed.

The Agency says the risk of liver reactions with this type of medicines if “well known” and has been kept under “close review” by its CHMP since the initial marketing authorisations were issued.

Risks are already reflected in the product information for products centrally authorised with the EMA and also addressed in the risk management plan for the medicines.

Between 1997 and January this year, the EMA says there were 21 cases of suspected serious liver toxicity in patients using Xenical for which a link to the medicines cannot be excluded. Of the 21 cases, the most recent analysis identified four cases of severe liver toxicity.

During May 2007 and January 2011, there were a total of nine reports of severe liver injury with Alli, although in some cases there were possible explanations for the hepatic issues.

Despite the number of severe cases, the Agency says they must be taken into consideration when 38 million patients use Xenical and 11 million people use Alli.

The CHMP is now harmonising the product information of information for the two centrally authorised medicines and will review all relevant data on the risk of hepatotoxicity before issuing an opinion whether the drugs should be revoked, suspended or changed.