Novartis Seeks China Approval for LDL-C Lowering Drug Inclisiran

Novartis (NVS.US) has submitted an application for the marketing approval of its first-in-class drug, Inclisiran, in China. The drug, a small interfering RNA (siRNA) therapy, is designed to lower low-density lipoprotein cholesterol (LDL-C) levels in patients with atherosclerotic cardiovascular disease (ASCVD) who have not received any lipid-lowering treatment and have elevated LDL-C levels. The application, which was accepted by the Center for Drug Evaluation (CDE), is a significant step forward for Novartis in the Chinese market.

Inclisiran is the first and only siRNA therapy approved for lowering LDL-C levels. It was initially approved in the European Union in 2020 and by the U.S. Food and Drug Administration (FDA) in 2021 for the treatment of high cholesterol and mixed dyslipidemia in adults. The drug's approval in these regions has demonstrated the potential of small nucleic acid therapies in the treatment of chronic diseases. To date, Inclisiran has been approved in nearly 100 countries worldwide, including the United States, the European Union, and China. In the European Union, it has received approval for four indications, in the United States for three indications, and in China for four indications.

The submission of Inclisiran for marketing approval in China is a strategic move by Novartis to expand its market presence in one of the world's largest pharmaceutical markets. The drug's unique mechanism of action, which involves silencing the PCSK9 gene to reduce LDL-C levels, makes it a valuable addition to the treatment options available for patients with ASCVD. The approval of Inclisiran in China is expected to provide a new treatment option for patients with elevated LDL-C levels who have not received any lipid-lowering treatment, further enhancing Novartis' position in the Chinese market.

Novartis' submission of Inclisiran for marketing approval in China is a testament to the company's commitment to innovation and its focus on addressing unmet medical needs. The drug's approval in China is expected to have a positive impact on the company's market presence and revenue in the region. With its unique mechanism of action and proven efficacy, Inclisiran has the potential to become a key player in the treatment of ASCVD in China, providing a new treatment option for patients with elevated LDL-C levels who have not received any lipid-lowering treatment.