ALNY - Novartis Alnylam cholesterol lowering drug granted FDA approval

The FDA has approved Leqvio (inclisiran) — developed by Alnylam Pharmaceuticals (NASDAQ:ALNY) and Novartis (NYSE:NVS) — to lower low-density lipoprotein cholesterol. In the U.S., Leqvio is the fourth small interfering RNA (siRNA) therapy and the first indicated to reduce lipoprotein cholesterol (also known as bad cholesterol or LDL-C). The FDA decision was based on data from Phase III ORION-9, -10 and -11 clinical trials where the drug was found to have cut LDL-C levels up to 52% vs. placebo with an effective and sustained response. Leqvio is expected to launch in January 2022, Novartis said. Under a license and collaboration agreement, Novartis (NVS) has global rights to commercialize the drug while Alnylam (ALNY) is entitled to tiered royalties at 10% – 20% on global sales.

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Novartis, Alnylam cholesterol lowering drug granted FDA approval