FDA approves Theravance’s lung drug for wider use

The U.S. Food and Drug Administration approved Theravance Inc’s antibiotic lung drug to treat a type of bacterial pneumonia affecting hospitalized patients, particularly those on ventilators.

The drug, Vibativ, will reach the market in the third quarter of 2013 for its expanded use. The drug is already approved in the United States and Canada to treat bacterial skin infections.

The disease, also known as nosocomial pneumonia, is a serious lung infection as patients, particularly those on ventilators, often cannot fight the infection.

The regulator said on Friday that Vibativ will be prescribed only when alternative treatments are not suitable and the expanded use is to treat only bacterial pneumonia due to staphylococcus aureus.

Vibativ is already approved in Europe for the treatment of adults with nosocomial pneumonia.

Theravance’s shares were up about 2 percent at $38.25 in after-market trading.

The shares closed up 10 percent at $37.5 on the Nasdaq following a Daily Mail’s market report that GlaxoSmithKline is lining up a $55 per share bid for Theravance.

###

Reuters