Theravance wins partial victory for Vibativ
An FDA panel voted 9 to 6 against recommending it for what Theravance had sought, its use for first-line treatment of nosocomial pneumonia (NP), but then voted 13 to 2 for the treatment of NP when other alternatives are not suitable. The drug is already approved in the U.S. for treating serious skin infections and in Europe for treating pneumonia, but the company has been having trouble getting it accepted for NP use in the U.S.
"We are pleased that the advisory committee believes there is a role for Vibativ in the treatment of nosocomial pneumonia, a serious disease that causes significant morbidity and mortality, particularly given rising microbial resistance to existing therapies," said Theravance CEO Rick E. Winningham.
The chairman of the review panel told MedPage Today, that the vote was closer than it looks. Dr.Thomas A. Moore, MD, said that while 9 of the 15 committee members voted no, including himself, many supported its use in some limited way. "When you have nosocomial pneumonia with MRSA, mortality goes up," Moore, of the University of Kansas School of Medicine in Wichita, told MedPage Today. But there were concerns about toxic effects on kidneys.
The FDA in 2009 asked for more data when Theravance sought approval then for treating NP. Earlier this year, Astellas Pharma parted ways with Theravance, ending a promotional partnership on Vibativ. Last year, a contractor ran into manufacturing problems with the drug. Since then, Reuters says, it has struck a deal with Hospira ($HSP) to make the injectable drug.