Alnylam Gets Second Product Approval Amid Stiff Competition
Zacks Investment Research | Nov 28, 2019 09:34PM ET
We issued an updated report on Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY) on Nov 28.
It is a development-stage biopharmaceutical company focused on the development of novel therapeutics based on RNA interference (RNAi).
In August 2018, the FDA approved Onpattro (patisiran) lipid complex injection, a first-of-its-kind RNA interference (RNAi) therapeutic, for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults. Onpattro is the first and only FDA-approved treatment for this indication. The uptake of the drug has been strong, with more than 600 patients worldwide on commercial Onpattro treatment since launch as of Sep 30, 2019. The drug should drive revenues for the company as it will be an important treatment option for people suffering from this often fatal disease.
In November, the FDA approved givosiran injection for subcutaneous use for the treatment of adults with acute hepatic porphyria (AHP). The approval came three months before the PDUFA date of Feb 20, 2020. Gvosiran injection will be marketed by the trade name of Givlaari. This is the second RNAi therapeutic from Alnylam approved by the FDA in the last sixteen months. Givlaari is expected to be available in the United States by the end of 2019. This approval should further boost sales for the company. The company plans to achieve regulatory approval from the European Medicines Agency (EMA) for Givlaari (givosiran) in early 2020 for the treatment of AHP. It also plans to execute on U.S. and EU commercial launches throughout 2020.
Shares of the company have soared 61.2% year to date compared with the Zacks Investment Research
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