Bristol Myers Sqibb (NYSE:BMY)
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Advisers to the European drug regulator recommended approval of an experimental diabetes drug that was rejected by U.S. regulators earlier this year amid concerns about its safety.
Shares of the drug's co-developers, Bristol-Myers Squibb Co. (BMY) and AstraZeneca PLC (AZN), rose after the recommendation, which surprised some analysts who had largely written off the drug, dapagliflozin, after the U.S. rejection. AstraZeneca's American depositary shares gained 1.7% to $46.15, while Bristol-Myers added 0.5% at $34.10.
While acknowledging safety concerns including a potential cancer risk, the European Medicines Agency's Committee for Medicinal Products for Human Use, or CHMP, said Friday that it recommended marketing authorization for dapagliflozin, which the companies plan to market under the brand Forxiga for treatment of type 2 diabetes. It is now up to the European Commission to decide on final approval, which could come within months.
"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," Bristol-Myers Chief Executive Lamberto Andreotti said in a press release.
Dapagliflozin is an inhibitor of a target in the kidney known as SGLT2. The drug is designed to block re-absorption of blood sugar and causes excretion of the glucose in urine, to treat type 2 diabetes, which is the most common form of diabetes.
Dapagliflozin would be the first drug of its kind to reach the market if it's approved. Other companies including Johnson & Johnson (JNJ) are developing SGLT2 inhibitors. Bristol discovered dapagliflozin and formed a diabetes partnership with AstraZeneca in 2007.
However, even if the drug reaches market, its commercial potential could be limited because of safety concerns.
Last year, an advisory committee to the U.S. Food and Drug Administration recommended against approval of dapagliflozin, citing clinical data showing higher-than-expected rates of breast and bladder cancer in patients who took the drug. FDA staff last year also cited concerns about liver toxicity.
In January, the FDA declined to approve the drug. The agency requested additional clinical data "to allow for a better assessment of the benefit-risk profile for dapagliflozin," the companies said at the time. This included results from ongoing studies and may require new clinical trials--something that could delay any FDA approval significantly.
The companies have said they remain committed to dapagliflozin's development, but haven't specified next steps in the U.S.
European regulatory advisers came to a different conclusion than the FDA, saying the drug's benefits outweigh its risks.
In a press release, the EMA said there is a need for additional treatment options for type 2 diabetes because of its increasing prevalence and the undesirable side effects associated with some current therapies.
In clinical trials, dapagliflozin improves blood-sugar control when given alone or in combination with certain other diabetes drugs, and sustained its effect up to 102 weeks, the EMA said.
The agency did say the finding of increased rates of bladder and breast tumors was a concern, "especially in the light of potentially long treatment periods and a possible widespread use."
The EMA advisory body will keep this potential risk under "close observation," and have requested that the companies conduct an epidemiological study of dapagliflozin.
Also, the EMA said the potential cancer risk will be examined in a planned study of potential cardiovascular risks of the drug.
This isn't the first time U.S. and European drug regulators have differed over the same drug. European regulators approved a Merck & Co. (MRK) cholesterol drug, Tredaptive, several years ago, but it's never been approved in the U.S.
A Pfizer Inc. (PFE) pulmonary arterial hypertension treatment, Thelin, was never approved by the FDA but was cleared in Europe and elsewhere. Pfizer, however, pulled the drug from the market in 2010 after reports of three deaths from liver injuries in users of the drug.
-Peter Loftus, Dow Jones Newswires; +1-215-982-5581; firstname.lastname@example.org