LONDON (Reuters) – European regulators backed approval of a new diabetes drug from AstraZeneca and Bristol-Myers Squibb on Friday, in a decision that contrasts with its failure to win approval in the United States.
Dapagliflozin belongs to a new class of diabetes drugs designed to allow more sugar to be excreted with urine and has the potential to be the first to treat the disease independent of the hormone insulin.
U.S. experts had raised concerns over the risk of cancer and liver injury associated with the medicine, prompting the U.S. Food and Drug Administration to issue a so-called “complete response letter” in January asking for more clinical data.
The green light for dapagliflozin from the European Medicines Agency (EMA) will now go to the European Commission for formal approval, a process that normally takes a couple of months.
The EMA decision marks a rare piece of good news for AstraZeneca, Britain’s second biggest drugmaker, which has suffered a series of product setbacks in recent months and is suffering from generic competition to several key drugs.
The European Medicines Agency also endorsed new drugs from Novartis and Takeda.
Novartis’s Jakavi is for myelofibrosis, a rare blood cancer, and was licensed from Incyte.
Takeda’s Rienso is an intravenous iron therapy that is partnered with AMAG Pharma .