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Novartis resubmitted its cholesterol-lowering drug inclisiran's application for marketing in the U.S. by transferring production

 Last Update: 2021-08-08
 Source: Internet
 Author: User

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In December last year, the FDA rejected Novartis’ siRNA cholesterol-lowering drug Leqvio (inclisiran) due to the inability to complete the production site inspection on time

Leqvio is an interfering RNA (siRNA) drug targeting PCSK9.

Leqvio is a core product that Novartis acquired from Medicines Pharmaceuticals at a cost of US$9.

In addition to rejections related to production verification, the new crown pandemic has also affected an important trial of the drug

Currently, Leqvio's data can only show that it can reduce harmful cholesterol levels

Novartis launched Leqvio in Germany and Austria in February this year for patients with extremely high cardiovascular risk

Reference source: Novartis revives inclisiran US filing by sidestepping FDA's manufacturing inspection concerns

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