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

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The FDA has approved Alnylam Pharmaceuticals Inc's 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 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.
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