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.”