FDA chief: Agency open to new pain drugs

WASHINGTON Fri Apr 13, 2007 1:44pm EDT

WASHINGTON (Reuters) - The U.S. Food and Drug Administration is still open to new Cox-2 pain drugs, the head of the agency said on Friday, one day after an advisory panel rejected Merck & Co. Inc.'s (MRK.N) follow-up drug to Vioxx.

"We'd be open to any new products coming forward, including Cox-2 inhibitors," FDA Commissioner Dr. Andrew von Eschenbach said in an interview with Reuters taped for C-SPAN television.

His comments follow an FDA panel of outside experts who voted 20-1 on Thursday against recommending approval of Merck's new arthritis drug, Arcoxia.

Cox-2 drugs have drawn scrutiny since Merck pulled Vioxx in 2004 after studies showed higher heart risks. Pfizer Inc.'s (PFE.N) similar drug, Bextra, was also withdrawn. The drugs, which are part of a larger class called non-steroidal anti- inflammatory drugs, or NSAIDs, target an enzyme involved in inflammation.

While the FDA is expected to make the final decision on Arcoxia later this month, it usually follows its panel's recommendations.

Still, von Eschenbach said the agency was willing to consider such new products as long as it took safety issues into account.

That could be good news for Novartis AG (NOVN.VX) (NVS.N), which is seeking U.S. approval for a new COX-2 inhibitor called Prexige. The Swiss drugmaker has already resubmitted its application to the FDA.

In the meantime, patients seeking relief still have other options, von Eschenbach said in the interview, which also included Dow Jones news agency.

"There are other alternatives that are already available in terms of painkillers that are available for chronic conditions including ones like arthritis," he said. "It's not as if there's nothing available. It's that anything else that becomes available we always must ... weigh the benefit and the risk."

In the interview, von Eschenbach also said current science is not yet ready to evaluate generic versions of complex protein-based biologic drugs.

Congress is considering a proposal to give the FDA new power to approve cheaper alternatives of such drugs, which treat cancer, anemia and other conditions. The large-molecule drugs, which are often injected, can cost thousands of dollars a year.

FDA has cleared generic versions of the simple protein for human growth hormone. Some experts also consider insulin a less complicated protein. But von Eschenbach said more complex biologic drugs would be more difficult to weigh.

"We don't have the science at this point to be able to address that full portfolio. We can do it with very, very small simple proteins but we can't yet do it with the very complex ones," he said.

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