Tag: ALS Drug

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 […]

March 22, 2023

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 […]

February 7, 2023

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, […]

January 24, 2023

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 […]

October 3, 2022

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 […]

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 […]

July 26, 2022

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 […]

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, […]