18 December 2020 - The U.S. FDA has not raised any concerns related to the efficacy or safety of inclisiran. The complete response letter is due to unresolved facility inspection related conditions.

The U.S. FDA has issued a complete response letter regarding the new drug application for inclisiran, a potential treatment for hyperlipidemia in adults who have elevated low-density lipoprotein cholesterol while being on a maximum tolerated dose of a statin therapy. 

The FDA stated that the agency cannot approve the new drug application by the Prescription Drug User Fee Act action date of 23 December 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 new drug application 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.

Read Novartis press release