Alnylam Pharma Reports 2022 Product And Pipeline Goals - Quick Facts

(RTTNews) - Alnylam Pharmaceuticals, Inc. (ALNY) said it expects to achieve FDA approval for Vutrisiran in early 2022 for the treatment of the polyneuropathy of hATTR amyloidosis in adults. The PDUFA date is April 14, 2022. The company plans to launch vutrisiran in the U.S. in early 2022.

Alnylam plans to file a supplementary New Drug Application for Patisiran in late 2022, assuming positive results from the APOLLO-B phase 3 study. Patisiran is a commercial-stage RNAi therapeutic targeting transthyretin for the treatment of polyneuropathy in patients with hATTR amyloidosis.

Alnylam plans to file an IND application in late 2022 for ALN-TTRsc04, an investigational RNAi therapeutic in development for the treatment of ATTR amyloidosis.

Alnylam plans to begin a phase 1 study with ALN-APP, an investigational RNAi therapeutic, in patients with early onset Alzheimer's Disease in early 2022. The company expects to report topline phase 1 results in late 2022.

Alnylam plans to initiate a phase 1 study with ALN-XDH, an investigational RNAi therapeutic in development for the treatment of gout, in early 2022. The company expects topline phase 1 results in late 2022. Also, Alnylam plans to continue advancement of its preclinical portfolio of investigational RNAi therapeutics targeting genes expressed in multiple tissue types, and plans to advance between 2-4 new IND applications from its organic product engine in 2022.