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After all, an FDA staff report ripped the drug on safety concerns last Friday. (See Bristol-Myers, AstraZeneca Face Safety Question on Drug) The drug is designed to help control blood sugar levels in adults with type 2 diabetes, but the FDA staff and the agency’s advisers are concerned that the treatment poses a risk of bladder and breast cancer.
The FDA advisory panel voted 9-6 against recommending approval of the drug. The FDA isn’t required to follow its experts’ advice but it rarely goes against a negative vote. The agency is expected to rule by late October.
The question is what the companies do next.
“Bristol-Myers Squibb and AstraZeneca remain committed to the dapagliflozin clinical development program and will continue to work closely with the FDA to support the review of this investigational compound,” the companies say in a statement.
The drug isn’t dead, Leerink Swann analyst Seamus Fernandez says. But he’s predicting a two-year delay in getting approval as the companies gather more long-term data for the drug’s safety and effectiveness. There’s an unmet need for a better diabetes drug to control glucose levels.
“Panel members want more data to clarify the magnitude of the risk ratio on breast and bladder cancers,” the analyst says.
Fernandez says he believes the companies may have a shot at getting European approval for the drug prior to an FDA clearance. EU advisers are expected to issue a decision on dapagliflozin later this year that would be used in considering an approval in Europe, and Fernandez says he thinks there’s a good chance the drug will get a favorable recommendation.
Tuesday’s FDA panel vote was important for several drug makers. Dapagliflozin is part of a new class of drugs known as SGLT2 inhibitors, which helps patients excrete blood sugar through urine.
Other companies are working on similar drugs, including Johnson Johnson (JNJ), Eli Lilly (LLY) with partner Boehringer Ingelheim and Isis Pharmaceuticals (ISIS). There are no SGLT2 inhibitors on the market yet.
Bristol-Myers’ shares fell 1% since Friday and AstraZeneca’s American shares dropped almost 2% through Tuesday’s close. Bristol-Myers closed at $28.81 Tuesday and is up about 9% this year. British-based AstraZeneca’s US shares closed at $48.73 Tuesday. They’re up more than 5% this year but are dropping in pre-market trading Wednesday morning.
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