Alnylam Seeking Lumasiran Approvals Soon, But Has Two Rivals On Its Heels
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.
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As with its first two approved RNAi therapies, Alnylam will negotiate value-based agreements with payers, but for Oxlumo, approved in pediatric patients, it will offer a patient need adjustment.
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.
UK patients diagnosed with primary hyperoxaluria Type 1 can now be prescribed lumasiran, which is still being reviewed for EU-wide approval. Patients in the US, Germany and other EU countries can also get the drug under early access schemes.