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  1. Onpattro (patisiran) FDA Approval History - Drugs.com

    Aug 15, 2018 · Onpattro FDA Approval History Last updated by Judith Stewart, BPharm on Aug 15, 2018. FDA Approved: Yes (First approved August 10, 2018) Brand name: Onpattro …

  2. Alnylam Announces First-Ever FDA Approval of an RNAi …

    Aug 10, 2018 · ONPATTRO was approved by the U.S. Food and Drug Administration (FDA) for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis …

  3. Patisiran - Wikipedia

    Patisiran was granted orphan drug status, fast track designation, priority review and breakthrough therapy designation due to its novel mechanism and the rarity of the condition it treats. [14][15] …

  4. Alnylam's Onpattro is first ever FDA-approved RNAi drug

    3 days ago · The FDA has approved the first ever RNA interference drug – Alnylam’s Onpattro (patisiran) for the nerve damage caused by the rare disease hereditary transthyretin-mediated …

  5. Please refer to your New Drug Application (NDA) dated December 11, 2017, received December 11, 2017, and your amendments, submitted under section 505(b) of the Federal Food, Drug, …

  6. The U.S. Food and Drug Administration today approved Onpattro (patisiran) infusion for the treatment of peripheral nerve disease (polyneuropathy) caused by hereditary transthyretin …

  7. When was Onpattro FDA approved? Its approval timeline …

    Dec 4, 2025 · Onpattro was FDA approved on August 10, 2018. Learn about this landmark approval for the first RNAi therapy to treat hATTR amyloidosis.

  8. Onpattro, The First FDA-approved RNAi Drug - BOC Sci

    On August 10, 2018, the US FDA approved Alnylam Pharmaceuticals' first RNA interference -based therapeutic drug Onpattro (Patisiran) for the treatment of peripheral neuropathy caused …

  9. Onpattro® - Vivo Infusion

    Jan 26, 2023 · Onpattro® (patisiran): Approved in August 2018 for the treatment of polyneuropathy in hATTR amyloidosis. For more information, please visit the Onpattro® …

  10. Onpattro (Patisiran) - Rare Disease Advisor

    Oct 9, 2013 · Onpattro was developed by Alnylam Pharmaceuticals and granted approval by the US Food and Drug Administration (FDA) in August 2018 for the treatment of adults with ATTR …