Tag: ALS Drug

Clinical Trials, Research and Development

Poor Trial Results May Prompt Maker to Pull ALS Drug Relyvrio From Market

March 11, 2024


Following disappointing trial results, the maker of a controversial ALS drug may pull the medication off the market. In a statement issued Friday, Amylyx Pharmaceuticals said that Relyvrio failed to help patients in a large follow-up study, but the company […]

FDA, Regulations

FDA advisers support conditional clearance of Biogen’s ALS drug

March 22, 2023

Via: Biopharma Dive

The Food and Drug Administration may have an easier time deciding how to approach a closely watched medicine for ALS it is reviewing, after a group of agency advisers appeared to support a conditional approval during a meeting Wednesday. The […]


Cigna restricts coverage of new ALS drug, deepening fears about access

February 7, 2023

Via: Biopharma Dive

One of the nation’s largest healthcare insurers has changed its policy for a new and in-demand ALS medicine, deciding not to cover it due to “a lack of clinical efficacy data.” Cigna considers the medicine, called Relyvrio, to be “experimental, […]

FDA, Regulations

ALS drug tofersen will face FDA advisors, says Biogen

January 24, 2023

Via: Pharmaphorum

The announcement in the Federal Register suggests that the FDA will seek advice on whether tofersen can be approved for a specific form of the neurodegenerative disease on the strength of biomarker data, and comes after the regulator had already […]

Pricing, Regulations

Amylyx ALS drug draws criticism over $158,000 price tag

October 3, 2022

Via: Pharmaphorum

Amylyx Pharmaceuticals’ Relyvrio – a new treatment for amyotrophic lateral sclerosis (ALS) approved by the FDA on Thursday, after review of the data from its phase 2 trial – was the next day set at a list price of $158,000 […]

FDA, Regulations

FDA Approves New ALS Drug Despite Uncertain Data

September 30, 2022


The U.S. Food and Drug Administration on Thursday gave its approval to a new drug for ALS (amyotrophic lateral sclerosis), also known as Lou Gehrig’s disease. But approval of the drug, called Relyvrio, is bound to stir new questions, with […]

FDA, Regulations

FDA, in another test of its flexibility, agrees to review Biogen’s closely watched ALS drug

July 26, 2022

Via: Biopharma Dive

Late last year, Biogen disclosed results from a closely watched study evaluating an experimental drug for Lou Gehrig’s disease, also known as ALS or amyotrophic lateral sclerosis. They showed the drug, called tofersen, wasn’t better than a placebo at slowing progression of […]

Clinical Trials, FDA, Regulations, Research and Development

FDA Advisory Panel Narrowly Votes Against New ALS Drug

March 31, 2022


In a close vote, an advisory panel for the U.S. Food and Drug Administration decided not to recommend the approval of an experimental drug for the deadly neurological disease amyotrophic lateral sclerosis (ALS). The panel’s decision had been closely watched, […]