Novartis inclisiran gets complete USFDA response letter for treating hyperlipidemia

"Novartis is confident in the quality of the regulatory submission for inclisiran, which includes a robust body of evidence related to efficacy and safety. We look forward to meeting with the FDA and our third-party manufacturing partner to discuss the feedback received and next steps," said John Tsai, Head Global Drug Development and Chief Medical Officer, Novartis. "We are committed to bringing this potential first-in-class small interfering RNA cholesterol-lowering treatment to patients as soon as possible."

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

Inclisiran (KJX839) is the first and only small interfering RNA (siRNA) therapy to reduce low-density lipoprotein cholesterol (LDL-C) levels via an RNA interference (RNAi) mechanism of action and could help improve outcomes for patients with atherosclerotic cardiovascular disease (ASCVD), a deadly form of cardiovascular disease. With two doses a year and effective and sustained LDL-C reduction, inclisiran works as a complement to statins. Inclisiran works differently from other therapies by preventing the production of the target protein in the liver, increasing hepatic uptake of LDL-C and clearing it from the bloodstream. Inclisiran is dosed initially, again at 3 months, and then once every 6 months. In three clinical trials, patients taking inclisiran maintained LDL-C reduction throughout each 6-month dosing interval. Administered in-office as a subcutaneous injection, inclisiran is expected to integrate seamlessly into a patient's healthcare routine.

Novartis has obtained global rights to develop, manufacture and commercialize inclisiran under a license and collaboration agreement with Alnylam Pharmaceuticals.