Novartis’ Cholesterol-lowering drug approval denied by US FDA

In News

• US FDA on 18th December declined the approval of Inclisiran that is a potential treatment for elevated low-density cholesterol in adults.

About

• The drug was approved by the European commission that was named as Leqvio. This was bought by the Novartis and expects to be a top seller.
• Approval was denied due to lack of inspection facility issues. Satisfactory resolution is required before it may be approved.
• Inclisiran is a drug used for the treatment of patients with atherosclerotic cardiovascular disease.

US FDA

• The US Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices.
• It also ensures the safety of the US food supply, cosmetics, and products that emit radiation.
• It regulates the manufacturing, marketing, and distribution of tobacco products.
• It is also responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable.