Targanta Therapeutics is getting ready for a day next month that will go a long way toward determining whether it can sell its first marketed product. The Cambridge, MA-based biotech company, said it has been asked to appear before an FDA advisory committee on Nov. 19 to make its case for why regulators should approve oritavancin as a new antibiotic for tough-to-treat skin infections.
Targanta’s application for approval includes data from 2,100 patients in clinical trials, including those who enrolled in two final-stage studies that reached their goals, the company said. The FDA deadline for reviewing the application is December 8.
Oritavancin, as we wrote about last month, is given in a three-to-seven day course of therapy. That means patients with nasty pathogens like drug-resistant 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’ Cubicin in a 7- to 14-day course of treatment, Targanta CEO Mark Leuchtenberger says. The dream with oritivancin, though, is for it to be given in a single shot, which at least one clinical trial has shown may be as effective or more effective than the standard three-to-seven day course. We’ll find out more details at an upcoming medical meeting.
The FDA panel will also review another antibiotic for complex skin infections, Theravance’s Telavancin. The South San Francisco-based company has had its application held up because of previously announced “data integrity” issues with its application, which led three clinical trial sites to be scrubbed out of the database. That’s the sort of thing that can lead to tough questioning from FDA reviewers, so they might not be in the best of moods to hear about the latest, greatest advances with antibiotics.