The US regulator issued Novartis with a complete response letter (CRL) for inclisiran in December, citing “unresolved facility inspection-related conditions” at a third-party manufacturing site run by Corden Pharma near Milan, Italy.
The resubmission to the FDA now lists one of its own sites in Austria as the manufacturing location for the final finished product, which it hopes will sidestep the issue and allow inclisiran to be approved in the US.
The small interfering RNA (siRNA) therapy has already been approved in Europe as Leqvio, and the FDA’s rejection was not caused by any issues with its efficacy or safety, according to Novartis.
