Merck-GSK team fails to turn FDA committee in Mevacor debate

WHITEHOUSE STATION, N.J. Not even the ninth-inning addition of savvy switch-veteran GlaxoSmithKline could convince Food and Drug Administration advisory committee members that Merck’s statin Mevacor would be appropriate for sale over-the-counter.

Merck officially expressed disappointment in a vote yesterday by a pair of FDA advisory committees that recommended FDA not switch the company’s statin Mevacor to OTC status, though company officials also reminded reporters that no FDA decision has been made yet. The anticipated action date by the FDA is Jan. 26, Merck reported.

“We felt we presented a compelling case to the committee that non-prescription Mevacor 20 mg would be a valuable option for motivated consumers who know they have moderately elevated cholesterol and certain risk factors, and are already talking with their healthcare provider,” stated Edwin Hemwall, vice president of global OTC regulatory and scientific affairs for Merck.

The next question is whether or not Merck will make a fourth pitch for a Mevacor switch. A GlaxoSmithKline spokesman declined to speculate following the vote, though with the last-minute addition of GSK to the switch process, leveraging the full strength of GSK’s switch expertise from the beginning could make the fourth time a charm for the Merck-GSK tandem.

The FDA certainly wouldn’t object. When asked during a press conference if the latest vote against an OTC Mevacor amounted to “three strikes and you’re out,” Andrea Leonard-Segal, FDA director of the nonprescription clinical evaluation division of the office of nonprescription products, said no. “We are open-minded [at the FDA],” she said.

The FDA advisory committee vote was 10 against a switch and two in favor with one abstention.