Alnylam submits MAA to the European Medicines Agency for investigational vutrisiran.
Positive 9-month results from the HELIOS-A Phase III study of vutrisiran were presented in April 2021 at the American Academy of Neurology (AAN) Virtual Annual Meeting. At 9 months, vutrisiran met the primary and all secondary endpoints, with statistically significant improvements in neuropathy, quality of life, and gait speed, and demonstrated an encouraging safety profile, relative to the external placebo group of the APOLLO study of patisiran. As aligned with the EMA, the results of the 18-month analysis from the HELIOS-A study will be provided to the Agency during its evaluation of the MAA.
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