Biotech

Arbutus Biopharma (Nasdaq:ABUS), an industry-leading Hepatitis B Virus (HBV) therapeutic solutions company, today announced that the Company’s lipid nanoparticle (LNP) licensee, Alnylam Pharmaceuticals, (Nasdaq:ALNY), announced that their new drug application (NDA) for ONPATTRO, an RNAi therapeutic, has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of hereditary ATTR amyloidosis with …

Arbutus Biopharma (Nasdaq:ABUS), an industry-leading Hepatitis B Virus (HBV) therapeutic solutions company, today announced that the Company’s lipid nanoparticle (LNP) licensee, Alnylam Pharmaceuticals, (Nasdaq:ALNY), announced that their new drug application (NDA) for ONPATTRO, an RNAi therapeutic, has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of hereditary ATTR amyloidosis with polyneuropathy.

As quoted in the press release:

“ONPATTRO is the first RNA interference therapeutic product to be approved by the FDA and represents a milestone for the technology as well as a revolutionary new treatment with the potential to transform the care of patients with hereditary transthyretin amyloidosis. Because ONPATTRO is enabled by our proprietary LNP technology, this approval triggers a royalty to Arbutus and provides us with important non-dilutive revenue to support our HBV cure mission, through several important clinical milestones next year,” said Dr. Mark Murray, Arbutus’ President and CEO. Dr. Murray added, “This approval also represents unprecedented clinical validation of our LNP technology which we have improved upon significantly since licensing it to Alnylam, and have recently granted broad rights to Genevant, a company we formed in the second quarter of 2018 that is jointly owned by Arbutus and Roivant Sciences. Genevant aims to advance multiple product candidates into the clinic across RNAi, mRNA, and gene editing modalities using the Arbutus LNP and ligand conjugate delivery platforms.”

Click here to read the full press release.

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