Plus   Neg

Novartis Gets CRL From FDA Due To Unresolved Facility Inspection-related Conditions On Inclisiran

Novartis (NVS) said that it received a complete response letter from the U.S. Food and Drug Administration regarding the new drug application for inclisiran. It is due to unresolved facility inspection-related conditions.

The FDA did not raise any concerns related to the efficacy or safety of inclisiran, the company said in a statement.

inclisiran is 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.

According to Novartis, 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. 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.

Novartis said it will work with the FDA and the third-party manufacturing facility in Europe to complete the inclisiran review, to bring this potential first-in-class siRNA to patients in the U.S. as quickly as possible.

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