Posted by Michael Wonder on 06 Jul 2021
Novartis tries to rescue stalled inclisiran filing with FDA
6 July 2021 - Novartis has tried to get its marketing application for high cholesterol therapy inclisiran in the US back on track, after the FDA rejected it last year, by changing the factory that makes the drug.
The US regulator issued Novartis with a complete response letter for inclisiran in December, citing “unresolved facility inspection-related conditions” at a third-party manufacturing site run by Corden Pharma near Milan, Italy.
