Arbutus’ LNP Licensee Alnylam Initiates Rolling Submission of New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) for Patisiran [Canadian Business Journal (Canada)]
Arbutus Biopharma Corporation (ABUS)
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Source: Canadian Business Journal
Arbutus’ LNP Licensee Alnylam Initiates Rolling Submission of New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) for Patisiran VANCOUVER, B.C. and WARMINSTER, Pa., Nov. 16, 2017 (GLOBE NEWSWIRE) — Arbutus Biopharma Corporation (Nasdaq: ABUS ), an industry-leading Hepatitis B Virus (HBV) therapeutic solutions company, announced today that the Company’s lipid nanoparticle (LNP) licensee Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY ), initiated submission of a rolling New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for patisiran, an investigational RNAi therapeutic being developed for patients with hereditary ATTR amyloidosis with polyneuropathy. This submission allows the FDA to review completed portions of the NDA on an ongoing basis. Alnylam expects to submit final clinical data by year end. “Our LNP licensing partner continues to make great progress towards achieving final regulatory approval for patisiran. T
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