Benzinga | Dec 23, 2021 08:20AM EST

FDA Approves Alnylam - Novartis' Leqvio As the First siRNA To Reduce Bad Cholesterol

The FDA has approved Alnylam Pharmaceuticals Inc's (NASDAQ:ALNY) Leqvio (inclisiran) to lower low-density lipoprotein cholesterol (LDL-C).

* Leqvio is indicated in the U.S. as an adjunct to diet and maximally tolerated statin therapy to treat clinical atherosclerotic cardiovascular disease or heterozygous familial hypercholesterolemia, requiring additional LDL-C lowering.

* Related: Read Why Analysts Are Going Bullish On This Large-Cap Pharma Stock.

* As of January 2020, Novartis AG (NYSE:NVS) obtained global rights to develop, manufacture, and commercialize inclisiran under a license and collaboration agreement.

* Novartis AG continues developing inclisiran and commercializing Leqvio worldwide, with Alnylam eligible to receive tiered royalties between 10 % - 20% on global sales.

* Leqvio is the fourth Alnylam-discovered medicine using its RNAi therapeutic platform to be approved to date.

* The Leqvio approval marks the first U.S. approval of an RNAi therapeutic indicated to treat a major risk factor for a highly prevalent disease.

* Related content: Benzinga's Full FDA Calendar.

* Price Action: ALNY shares closed at $187.38 on Wednesday, and NVS stock is up 0.50% at $86.74 during the premarket session on the last check Thursday.