FDA backs Theravance antibiotic, rejects Targanta's

Theravance won the crucial backing of an FDA advisory committee for its new antibiotic for serious skin infections. The panel voted 21 to 5 to recommend approval of telavancin, which is also designed to treat MRSA infections that don't respond to currently used antibiotics.

But the advisory panel narrowly voted against Targanta [1]'s antibiotic after voicing their complaint that oritavancin had not yet demonstrated an ability to treat the most serious types of infections. Targanta's trials predated the appearance of the most serious types of infections, leaving the experts no data to consider on that score.

"People want an effective drug, but we just haven't seen enough evidence here with regard to the contemporary problem," said panel chair Dr. Barth Reller. "The consistent message is we need more evidence to be comfortable on the question of the effectiveness of this drug."

An FDA report, meanwhile, noted that telavancin worked as well as vancomycin treating skin infections. Comparing responses to the two antibiotics among patients with MRSA, the agency reported a numerical superiority for telavancin that didn't reach the bar for statistical superiority.

"I voted yes because I think vancomycin is sort of a dying drug," said W. Kemper Alston, an associate professor of medicine at the University of Vermont in Burlington.

The FDA has noted its concerns that patients taking telavancin suffered from a higher rate of kidney problems than those taking vancomycin. But the side effects were generally reversed once treatment ended.

- read the report [2] from the Wall Street Journal 
- read the AP story [3]

Related Articles:
FDA assess two antibiotics up for review [4]
FDA to review Theravance's telavancin response [5]
Drug work completed, Theravance cuts 40% of staff [6]