Alnylam Plans Lumasiran Phase III As Market Landscape Gets Competitive
Alnylam will take on the global development and commercialization of investigational rare disease therapy lumasiran as Sanofi declines to opt-in to its development, and the US biotech prepares to commercialize its first RNAi therapeutic, pencilled in for later this year.
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The top-line data in the ultra-rare disease are also the first to demonstrate safety and efficacy of an RNAi therapy in patients six years and younger.
Phase III results support early 2020 filings for what could be the RNAi specialist’s third commercial product, but two competing drugs for primary hyperoxaluria from Dicerna and OxThera aren’t far behind.
Although Dicerna needs to make some payments to Alnylam to settle a patent infringement case, the company has avoided an expensive court trial and is free to find partners for its early-stage RNAi therapeutics programs.