(Update: The fourth paragraph includes a statement from Targanta about the panel’s vote.)
Targanta Therapeutics was dealt a blow late this afternoon. A panel of expert advisers to the FDA voted by a 10-8 margin that the Cambridge, MA-based company’s experimental antibiotic for complex skin infections hasn’t yet shown enough evidence that it’s safe and effective, according to an AP report.
The FDA isn’t required to follow the recommendations of its advisory panels, but it usually does. That means Targanta could have more work to do before it can win clearance to sell the drug on the U.S. market. The setback is doubly painful, since the FDA panel recommended approval of a competing antibiotic in development from South San Francisco-based Theravance (NASDAQ: [[ticker:THRX]]). The panel’s recommendation will surely catch Wall Street off-guard; Targanta’s shares surged 47 percent after documents released by FDA staff on Monday appeared to show reviewers were favorably inclined toward Targanta’s application.
Oritavancin, as we wrote in September, is given in a three-to-seven day course of therapy. That means patients with nasty bacterial infections like MRSA could end up spending less time in the hospital than if they take generic vancomycin in twice-daily infusions for 10 to 14 days, or Cubist Pharmaceuticals’ daptomycin (Cubicin) in a 7- to 14-day course of treatment.
“We obviously are disappointed with the recommendation of the Advisory Committee,” said Targanta CEO Mark Leuchtenberger, in a statement. He added that the company continues to believe in the product, and it will continue to have discussions with FDA staff about its application. The FDA’s deadline to complete its review is Dec. 8, although the agency has been missing a lot of deadlines lately, so it shouldn’t be a surprise if this isn’t settled until after New Year’s Day.
