Theravance said FDA seeks more data for second indication for its drug Vibativ

FDA seeks more data for Theravance drug

SOUTH SAN FRANCISCO, Calif. — Theravance Inc. said Thursday regulators are not satisfied with its data to back a second use for its infection drug Vibativ, and the drug developer indicated further clinical studies might be required to win marketing approval for the indication.

Vibativ, or telavancin, was approved in September as a treatment for complicated skin infections. Theravance and its partner Astellas Pharma launched the drug Nov. 5.

A year ago, the company asked the Food and Drug Administration to also approve the drug for the treatment of hospital-acquired pneumonia.

On Thursday, Theravance said the FDA asked for more data about the drug, and about studies Theravance has conducted in support of its application for the second indication.

The agency will not begin a formal review of the drug until it says it is satisfied with the data.

Vibativ, or telavancin, is an injection intended to treat complicated or drug-resistant infections like methicillin-resistant Staphylococcus aureus, also called MRSA or the “superbug.”

According to Theravance, the FDA did not say Theravance would have to run a new clinical trial to gain approval, but it suggested a design for such a study. Theravance said it does not know what the FDA wants and said the agency did not provide any suggestions about the goals of the proposed study, how many patients should be included, or even how many studies might be required.

In response to the FDA’s previous requests, Theravance said it combined data from two late stage trials of Vibativ, with the goal of making the data more comparable. It said the FDA told it that the data is equal to only one study. Two late-stage trials are often required to win approval.

Theravance said it has tested Vibativ on about 1,500 patients and said its studies are the largest that have been submitted in support of a new drug of its type.

Regulatory concerns about Vibativ include a risk of birth defects when it is used in pregnant women, manufacturing issues, and questions about data comparing the drug to vancomycin, which is the most powerful antibiotic currently on the market.

In aftermarket trading, Theravance shares lost 81 cents, or 6 percent, to $12.69. Shares earlier slid 35 cents, or 2.5 percent, to end regular trading at $13.50. The stock has traded between $11.82 and $18.56 over the last year.

(This version CORRECTS that application is for a second indication for the drug and clarifies throughout)