Novartis’ Cholesterol-lowering drug approval denied by US FDA : Daily Current Affairs

Novartis’ Cholesterol-lowering drug approval denied by US FDA

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

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.

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.