Alnylam Therapeutics (NASDAQ:ALNY) outlines product goals at the company’s R&D Day in New York City.
The company expects to achieve regulatory approval for Givlaari from the European Medicines Agency in early 2020 and execute on U.S. and E.U. commercial launches throughout 2020. Additional results are anticipated to be filed from the ENVISION Phase 3 study in mid-2020. Alnylam expects to file for regulatory approvals and launch in additional countries in 2020.
Alnylam also expects to continue global commercial execution for Onpattro and receive approval of the treatment in Brazil in mid-2020, with planned launches in additional countries throughout 2020.
For Lumasiran, the company expects to file a NDA and a marketing authorisation application with the FDA and EMA, respectively, in early 2020.
Source: Press Release
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