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Merck's (NYSE: MRK ) going to have to wait a little longer to wake up from this nightmare. The pharma giant said the Food and Drug Administration is delaying the decision about Bridion, its drug that helps patients wake up after anesthesia.
The drug was first submitted to the FDA by Schering-Plough before Merck bought the company. In 2008, an advisory panel voted unanimously recommending approval of the drug, but the FDA went against its advisors and rejected the drug. It's not the first time -- InterMune's (NASDAQ: ITMN ) Esbriet and Dendreon's (NASDAQOTH: DNDNQ ) Provenge the first time -- but it hurts nonetheless, especially since neither Esbriet nor Provenge got a unanimous vote of confidence from their advisory panels, so it wasn't quite as unexpected as Bridion's rejection was.
Adding salt to the wound, Bridion, like Esbriet, was approved by European regulators. Bridion had global sales of $261 million last year, but none in the U.S. where it still isn't on the market.
Merck took over Schering-Plough and gathered the clinical trial data that the agency wanted. The agency had safety concerns relating to potential allergic reactions and bleeding events. They seem to be overblown considering the current sales level.
Merck submitted its response to the FDA and was expecting to hear from the agency in the first half of this year. But the FDA recently notified the company that it was extending the review by three months. The agency shoots for reviewing resubmission within six months, but delays the process when it asks for clarifications.
Merck didn't say that it submitted any new data during the review, so maybe that isn't the issue. Maybe the FDA is feeling the sequestration crunch.
Whatever it is, the FDA needs to take a little Bridion to wake up and get this drug approved already.
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