Theravance has received a complete response letter from the FDA related to the telavancin New Drug Application (NDA) for the treatment of nosocomial pneumonia (NP). Telavancin is a bactericidal, once-daily injectable investigational antibiotic for the treatment of NP caused by gram-positive bacteria such as methicillin-resistant Staphylococcus aureus (MRSA).
The complete response instructed Theravance that submission of additional data and analysis for the NP 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 NP clinical trials included clinical response as the primary endpoint, consistent with current draft FDA guidelines for antibacterial clinical trial design in NP, and all-cause mortality as a secondary endpoint.
In the complete response, 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 NP 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 NDA or may require that additional studies be conducted.
The company said that Vibativ (telavancin) is approved in the US and in Canada for the treatment of adult patients with complicated skin and skin structure infections (cSSSI) caused by susceptible isolates of the gram-positive microorganisms like Staphylococcus aureus (including methicillin-susceptible and -resistant isolates), Streptococcus pyogenes, S agalactiae, S anginosus group (includes S anginosus, S intermedius and S constellatus) and Enterococcus faecalis (vancomycin-susceptible isolates only).
Rick Winningham, chief executive officer of Theravance, said: “The requests in the complete response letter are generally in line with our expectations, and we believe these requests can be addressed promptly. We believe that we have already collected the information and completed the analysis required to respond to the FDA.
“Importantly, the additional data collected to date support our prior conclusions about the telavancin attain studies. We look forward to submit our response and continuing to work with the FDA on this NDA.”