Alnylam submits new drug application with U.S. FDA for vutrisiran for the treatment of the polyneuropathy of hereditary ATTR amyloidosis in adults

Alnylam Pharmaceuticals

19 April 2021 - Alnylam has submitted a new drug application to the U.S. FDA for the approval of vutrisiran for the treatment of the polyneuropathy of hATTR amyloidosis in adults. 

Vutrisiran has been granted orphan drug designation in the U.S. and the European Union for the treatment of ATTR amyloidosis. Vutrisiran has also been granted a fast track designation in the U.S. for the treatment of the polyneuropathy of hATTR amyloidosis in adults. 

The Company plans to follow the FDA submission with regulatory filings in Brazil and Japan. The Company also plans to submit a marketing authorisation application in the EU upon obtaining the results of the 18-month analysis from the HELIOS-A Phase 3 Study, as previously aligned with the EMA.

Read Alnylam Pharmaceuticals press release

Michael Wonder

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Michael Wonder

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Medicine , US , Orphan drug , Dossier