Novartis Resubmits Application for Inclisiran

Novartis has announced it has resubmitted its New Drug Application for inclisiran to treat hyperlipidemia in adults who have elevated low-density lipoprotein cholesterol (LDL-C).

In December 2020, the FDA issued a Complete Response Letter for inclisiran because of issues related to a third-party manufacturing facility. In its resubmission, Novartis indicated that it is listing its own site in Schaftenau, Austria, as the manufacturing location for the finished product. Novartis indicated that the transfer of the manufacturing of inclisiran to Austria was planned and initiated in 2020, prior to the receipt of the CRL.

The FDA did not raise any concerns related to the efficacy or safety of inclisiran.

Inclisiran is a small interfering RNA (siRNA) therapy to reduce low-density lipoprotein cholesterol levels via an RNA interference mechanism of action and could help improve outcomes for patients with atherosclerotic cardiovascular disease. It works by preventing the production of the target protein in the liver, increasing hepatic uptake of LDL-C and clearing it from the bloodstream. With two doses a year and effective and sustained LDL-C reduction, inclisiran works as a complement to statins.

The European Commission granted Novartis marketing authorization for Leqvio (inclisiran) in Europe on December 11, 2020.

Novartis had obtained rights to inclisiran from Alnylam Pharmaceuticals.