FDA approves Theravance's lung drug for wider use

Fri Jun 21, 2013 6:16pm EDT

A view shows the U.S. Food and Drug Administration (FDA) logo at the lobby of its headquarters in Silver Spring, Maryland August 14, 2012. REUTERS/Jason Reed

A view shows the U.S. Food and Drug Administration (FDA) logo at the lobby of its headquarters in Silver Spring, Maryland August 14, 2012.

Credit: Reuters/Jason Reed

Related Topics

(Reuters) - 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. (link.reuters.com/hez98t)

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.

FILED UNDER:
We welcome comments that advance the story through relevant opinion, anecdotes, links and data. If you see a comment that you believe is irrelevant or inappropriate, you can flag it to our editors by using the report abuse links. Views expressed in the comments do not represent those of Reuters. For more information on our comment policy, see http://blogs.reuters.com/fulldisclosure/2010/09/27/toward-a-more-thoughtful-conversation-on-stories/
Comments (1)
SeniorMoment wrote:
The right prescription drug has to be determined individually for each patient, so it is best for doctors and patients both to have a choice of preferred drugs to try, since culturing the cause of an infection rarely takes less than 48 hours.

Jun 22, 2013 10:09pm EDT  --  Report as abuse
This discussion is now closed. We welcome comments on our articles for a limited period after their publication.

Pictures