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Relyvrio FDA Approval History

Last updated by Judith Stewart, BPharm on April 7, 2024.

FDA Approved: Yes (Discontinued) (First approved September 29, 2022)
Brand name: Relyvrio
Generic name: sodium phenylbutyrate and taurursodiol
Dosage form: Powder for Oral Suspension
Previous Name: AMX0035
Company: Amylyx Pharmaceuticals, Inc.
Treatment for: Amyotrophic Lateral Sclerosis

Relyvrio (sodium phenylbutyrate and taurursodiol) is a neuroprotective therapy for the treatment of amyotrophic lateral sclerosis (ALS).

On April 4, 2024, Amylyx Pharmaceuticals, Inc. announced the Company has started a process with the U.S. Food and Drug Administration (FDA) and Health Canada to voluntarily discontinue the marketing authorizations for Relyvrio/Albrioza (sodium phenylbutyrate and taurursodiol) and remove the product from the market in the U.S. and Canada based on topline results from the Phase 3 PHOENIX trial. Relyvrio/Albrioza will no longer be available for new patients. Patients currently on therapy in the U.S. and Canada who, in consultation with their physician, wish to stay on treatment can be transitioned to a free drug program.

Development timeline for Relyvrio

Apr  4, 2024Amylyx Pharmaceuticals Announces Formal Intention to Remove Relyvrio from the Market
Mar  8, 2024Amylyx Pharmaceuticals Announces Topline Results From Global Phase 3 PHOENIX Trial of AMX0035 in ALS
Sep 29, 2022Approval FDA Approves Relyvrio (sodium phenylbutyrate/taurursodiol) for Patients with Amyotrophic Lateral Sclerosis (ALS)
Sep 29, 2022FDA Approves New Treatment Option for Patients with ALS
Sep  7, 2022Amylyx Pharmaceuticals Announces FDA Advisory Committee Supports Approval of AMX0035 for the Treatment of ALS
Jun  3, 2022Amylyx Pharmaceuticals Receives Notification of PDUFA Date Extension for AMX0035 for the Treatment of ALS
Mar 18, 2022Amylyx Pharmaceuticals Announces Launch of U.S. Expanded Access Program for AMX0035
Dec 29, 2021Amylyx Pharmaceuticals Announces FDA Acceptance and Priority Review of New Drug Application (NDA) for AMX0035 for the Treatment of ALS
Nov  9, 2021Amylyx Pharmaceuticals Announces Results from PEGASUS Trial of AMX0035 in Alzheimer’s Disease at the Clinical Trials on Alzheimer’s Disease (CTAD) Conference
Nov  4, 2021Amylyx Pharmaceuticals Announces Participants Dosed in the Global Phase 3 PHOENIX Study of AMX0035 in ALS
Nov  2, 2021Amylyx Pharmaceuticals Submits New Drug Application (NDA) for AMX0035 for the Treatment of ALS
Sep 15, 2021Amylyx Pharmaceuticals Announces Plan to Submit New Drug Application (NDA) for AMX0035 for the Treatment of ALS in the Coming Months
Sep  2, 2020Amylyx Pharmaceuticals Announces New England Journal of Medicine Publication of Pivotal AMX0035 Data Demonstrating Statistically Significant Benefit in People with ALS
Aug  8, 2017Amylyx Pharmaceuticals Doses First Patient in Phase II Clinical Trial of AMX0035 for the Treatment of Amyotrophic Lateral Sclerosis

Further information

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