FDA assess two antibiotics up for review

Reviewers for the FDA say that Theravance's experimental antibiotic telavancin [1] was "possibly" related to some of the deaths reported among volunteers taking the drug. In an analysis released today, the drug reviewers said that the drug appeared to be as effective as vancomycin in fighting infections. And they added that telavacin would be an important new antibiotic which could be used to treat people whose infections resisted the older antibiotics on the market.

The FDA also concluded that the data Theravance submitted for the antibiotic were reliable, saying that there were few problems associated with clinical sites that remained after they tossed the results from five clinics saying that they were deficiencies in good clinical practices.

- here's the FDA's review [2] of telavancin
- and here's the Dow Jones story [3]

ALSO: Shares of Targanta, meanwhile, spiked on the news that FDA staffers had concluded that its antibiotic appeared as safe and effective as currently available antibiotics. Report [4]

Related Articles:
Drug work completed, Theravance cuts 40% of staff [1]
FDA to review Theravance's telavancin response [5]