FDA Wants More Data on Pneumonia Drug Telavancin

The Food and Drug Administration is asking the maker of the proposed pneumonia drug Telavancin to provide more information and conduct additional clinical trials before the agency will approve the drug.

Theravance Inc. wants the FDA to approve its drug to treat nosocomial pneumonia. Last year, the FDA asked the company for more data before granting an approval. This week, the FDA asked for additional clinical study of the drug, officials said.

“It is unclear at this point what additional information the FDA will require to complete their review of the nosocomial pneumonia new drug application,” Theravance Chief Executive Rick Winningham said in a statement, according to a Reuters news report.

The company said the FDA has not provided additional information about the size or number of additional studies required or which statistical methods must be used for evaluation of clinical results. It also is unclear what specific concerns the FDA has about the safety of efficacy of Telavancin as a pneumonia treatment.

Telavancin is already approved as a treatment for complicated skin and skin structure infections, but the company is seeking broader FDA approvals to use the drug in treating the form of pneumonia.

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