Theravance, Inc. (THRX) said Friday that it received a complete response letter from the U.S. Food and Drug Administration related to the telavancin new drug application for the treatment of nosocomial pneumonia.
The complete response letter instructed Theravance that submission of additional data and analyses for the nosocomial pneumonia patient population to support an evaluation of all-cause mortality as the primary efficacy endpoint is necessary to demonstrate the safety and efficacy of telavancin.
The telavancin nosocomial pneumonia clinical trials included clinical response as the primary endpoint, consistent with current draft FDA guidelines for antibacterial clinical trial design in nosocomial pneumonia, and all-cause mortality as a secondary endpoint.
In the complete response letter, the FDA also requested further rationale for the pooling of the data from the two ATTAIN studies, noted the need for a pediatric drug development plan for the nosocomial pneumonia indication and a customary safety update.
If the additional data and analyses that Theravance submits to the FDA are deemed insufficient, FDA may not approve the new drug application or may require that additional studies be conducted.
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