FDA issues complete response to filing of Leqvio for hyperlipidemia.- Novartis

The U.S. FDA has issued a complete response letter (CRL) regarding the new drug application (NDA) for Leqvio (inclisiran), from Novartis, a potential treatment for hyperlipidemia in adults who have elevated low-density lipoprotein cholesterol (LDL-C) while being on a maximum tolerated dose of a statin therapy. The FDA stated that the agency cannot approve the NDA by the Prescription Drug User Fee Act (PDUFA) action date of December 23, 2020, due to unresolved facility inspection-related conditions. The conditions will be conveyed to the European manufacturing facility within 10 business days. The third-party facility is responsible for drug product manufacturing. Satisfactory resolution of the unresolved facility inspection-related conditions is required before the Novartis NDA may be approved. No onsite inspection was conducted. If it is determined that a facility inspection is needed to approve the application, the FDA will define an approach for scheduling once safe travel may resume based on public health need and other factors.The EC granted Novartis marketing authorization for Leqvio (inclisiran) in Europe on December 11, 2020.