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ARTICLE · 30 AUGUST 2018

FDA Approval For RNAi Therapeutic Provides Boost For Entire Field

Davies Collison Cave
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In a much welcomed sign for researchers, companies and investors alike in the field of nucleic acid-based therapeutics, on 10 August 2018 the US Food and Drug Administration (FDA) approved

AustraliaIntellectual Property
Tania Uren
Tania Uren
Gavin Recchia
Gavin Recchia
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In a much welcomed sign for researchers, companies and investors alike in the field of nucleic acid-based therapeutics, on 10 August 2018 the US Food and Drug Administration (FDA) approved the use of ONPATTRO™ (patisiran) for the treatment of polyneuropathy caused by hereditary transthyretin-mediated (hATTR) amyloidosis in adults. ONPATTRO™ is a RNA interference (RNAi) therapeutic developed by Alnylam Pharmaceuticals, Inc., containing lipid-encapsulated small interfering RNA (siRNA) molecules that target and silence the mutated transthyretin gene in patients with hATTR amyloidosis.

This is the first RNAi therapeutic approved by the FDA, and represents a coming-of-age for nucleic acid-based therapeutics after what has been a very long and challenging road. Demonstrating the commercial and clinical viability of nucleic acid-based therapeutics, this should also signal a new lease on life for patents and patent applications focused on such molecules.

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