Therapy Areas: Central Nervous System
FDA Advisory Committee Will Reconvene to Review New Drug Application for AMX0035 for the Treatment of ALS on 7 September
8 August 2022 - - The US Food and Drug Administration's Peripheral and Central Nervous System Drugs Advisory Committee (PCNSDAC) will reconvene to review the New Drug Application for AMX0035 (sodium phenylbutyrate and taurursodiol [also known as ursodoxicoltaurine]) for the treatment of amyotrophic lateral sclerosis, US-based US-based Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) said.

The second virtual meeting of the PCNSDAC to discuss the AMX0035 NDA is scheduled, as published in the Federal Register, for September 7, 2022.

The PCNSDAC previously met on March 30, 2022, to discuss the NDA for AMX0035 for the treatment of ALS.

The FDA is reconvening the committee to discuss the additional analyses of data from the company's clinical studies that were determined by the FDA to constitute a major amendment to the NDA.

As a result, FDA extended the Prescription Drug User Fee Act (PDUFA) target action date for the AMX0035 NDA to September 29, 2022, from the original date of June 29, 2022.

AMX0035 (sodium phenylbutyrate and taurursodiol) is an oral fixed-dose medication with marketing applications pending in the United States and European Union, and approved with conditions as Albrioza to treat amyotrophic lateral sclerosis in Canada.

The combination of sodium phenylbutyrate and taurursodiol may reduce neuronal cell death, hypothesized to occur by simultaneously mitigating endoplasmic reticulum stress and mitochondrial dysfunction.

AMX0035 is also being explored for the potential treatment of other neurodegenerative diseases.

Amylyx Pharmaceuticals, Inc. is committed to supporting and creating more moments for the neurodegenerative community through the discovery and development of innovative new treatments.

Amylyx is headquartered in Cambridge, Massachusetts and has operations in Canada and EMEA.


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