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