said Thursday after market close that a U.S. Food and Drug Administration panel will meet to review its new-drug application for skin-infection drug Telavancin.
The San Francisco-based biopharmaceutical company said it recently learned that the agency's Anti-Infective Drugs Advisory Committee soon will meet to discuss the once-daily injection, which is intended to treat infections caused by Gram-positive bacteria, including resistant pathogens like MRSA. The issues to be discussed weren't disclosed, and the company said it will divulge more when additional information is available.
Such panels are summoned to consider questions or concerns that come up in the review process and will issue a recommendation for whether the FDA should or shouldn't approve a drug. The FDA isn't bound to follow these recommendations, but usually does.
Theravance, which has a collaboration with Astellas Pharma to develop and commercialize Telavancin, saw shares fall $3.30, or 15.5%, to $18 on very light volume in recent post-market trading.