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Givlaari FDA Approval History

Last updated by Judith Stewart, BPharm on Dec 20, 2019.

FDA Approved: Yes (First approved November 20, 2019)
Brand name: Givlaari
Generic name: givosiran
Dosage form: Injection
Company: Alnylam Pharmaceuticals, Inc.
Treatment for: Acute Hepatic Porphyria

Givlaari (givosiran) is an aminolevulinate synthase 1-directed small interfering RNA (siRNA) indicated for the treatment of adults with acute hepatic porphyria (AHP).

Development Timeline for Givlaari

DateArticle
Nov 20, 2019Approval  FDA Approves Givlaari (givosiran) for Acute Hepatic Porphyria
Aug  5, 2019Alnylam Announces U.S. Food and Drug Administration (FDA) Granted Priority Review of the Givosiran New Drug Application (NDA) for the Treatment of Acute Hepatic Porphyria
Jun  5, 2019Alnylam Completes Rolling Submission of New Drug Application to U.S. Food and Drug Administration (FDA) for Givosiran for the Treatment of Acute Hepatic Porphyria
Apr 12, 2019Alnylam Presents Positive Complete Results from ENVISION Phase 3 Study of Givosiran, an Investigational RNAi Therapeutic for the Treatment of Acute Hepatic Porphyria
Mar  6, 2019Alnylam Reports Positive Topline Results from ENVISION Phase 3 Study of Givosiran in Acute Hepatic Porphyria
Oct 15, 2018Alnylam Announces Plan to Initiate Rolling Submission of a New Drug Application and Pursue Full Approval for Givosiran
Aug 21, 2018Alnylam Completes Enrollment in ENVISION Phase 3 Study of Givosiran, an Investigational RNAi Therapeutic for the Treatment of Acute Hepatic Porphyrias (AHPs)
Apr 14, 2018Alnylam Presents New Positive Clinical Results for Givosiran, an Investigational RNAi Therapeutic for the Treatment of Acute Hepatic Porphyrias
Nov  7, 2017Alnylam Initiates ENVISION Phase 3 Clinical Study with Givosiran, an Investigational RNAi Therapeutic for the Treatment of Acute Hepatic Porphyrias (AHPs)
May 31, 2017FDA Grants Breakthrough Therapy Designation for Alnylam's Givosiran for the Prophylaxis of Attacks in Patients with Acute Hepatic Porphyria

Further information

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