Alnylam closes in on approval of third RNAi therapeutic
US biotech Alnylam Pharmaceuticals (Nasdaq: ALNY) cemented its standing as the leading RNAi therapeutics company on Tuesday by presenting positive Phase III data on its latest candidate.
Following in the footsteps of Alnylam’s two approved therapies, lumasiran met all primary and secondary tested endpoints in the ILLUMINATE-A study in primary hyperoxaluria type 1 (PH1), with significant reduction in urinary oxalate levels relative to placebo.
Based on these results, Alnylam plans to submit a New Drug Application in the USA and file a Marketing Authorisation Application to the European Medicines Agency for lumasiran in early 2020.
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