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US FDA approves Vibativ for lung infection caused by MRSA

Theravance’s drug backed to treat hospital-acquired bacterial pneumonia

US FDA approves Vibativ for lung infection caused by MRSA

Theravance last week won US approval for its once-daily injection Vibativ for the treatment of a lung infection picked up by patients in hospital.

The Food and Drug Administration (FDA) expanded the approval of Vibativ (telavancin) to cover use in the treatment of patients with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by the bacterium Staphylococcus aureus.

Strains of S. Aureus include methicillin-susceptible (MSSA) and methicillin-resistant (MRSA), which has become notorious as a hospital infection for its resistance to antibiotics and difficulty to treat.

"Pneumonia is associated with one of the highest mortality rates among hospital-acquired infections and increases hospital stay and costs of care,” said Dr Ralph Corey, professor of medicine at the Duke University Medical Center and a principal investigator for Vibativ.

“MRSA pneumonia, in particular, is an increasingly challenging infection as there are few approved treatments available today and resistance to current antibiotics remains a problem. Vibativ offers effectiveness in these difficult to treat infections when alternative therapies are not suitable."

The approval is based on two clinical trials that enrolled more than 1,500 patients randomly assigned to Vibativ or the antibiotic vancomycin.

According to the FDA, mortality rates 28 days after initiation of treatment were comparable between the two arms, except for patients who had pre-existing kidney problems.

As a result, Vibativ's approval comes with a boxed warning about its effect on new or worsening kidney problems in patients.

Nevertheless, Vibativ provides another treatment option for a condition with few options, and Rick Winningham, Theravance's CEO gave details of the company's marketing plans.

“Theravance plans to make Vibativ available for purchase through wholesalers in the third quarter of 2013 and is continuing to evaluate commercialisation alternatives for the US market,” he said.

The lung infection indication adds to Vibativ's existing FDA approval to treat complicated skin and skin structure infection.

24th June 2013

From: Sales

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