WASHINGTON– A treatment for Amyotrophic Lateral Sclerosis (ALS) will be removed from the market in USA and Canada after a new clinical trial did not provide conclusive results on its effectiveness, announced its creator company, Amylyx Pharmaceuticals.
In a statement, the American pharmaceutical company specified that it will suspend the sale of the drug, intended to slow down the progression of this neurodegenerative disease and marketed under the name Relyvrio in the United States and Albriosa in Canada.
“While this is a difficult time for the ALS community, we have reached this decision in collaboration with the stakeholders who will be affected and in line with our strong commitment to people living with ALS and other neurodegenerative diseases,” they stated in the text Joshua Cohen and Justin Klee, co-CEOs of the company.
US health authorities had approved the drug in 2022, in a controversial decision that was based on a small initial clinical trial involving only 137 participants.
Its authorization was then defined by the severity of the illness, for which there are few treatments and which is currently incurable.
Also known as Charcot disease, ALS causes progressive paralysis of the muscles that gradually prevents walking, eating, breathing or speaking, creating a state of confinement for the patient, whose brain and intellectual abilities remain intact. Once diagnosed, life expectancy is usually three to five years.
Clinical trial
The withdrawal of Amylyx Pharmaceuticals’ drug follows the disclosure in March of data from a larger clinical trial involving 664 ALS patients, which found no significant differences in outcomes between those in the treatment group and those who received a placebo. .
The company also announced that it will reduce its workforce “by approximately 70%” to focus on another experimental drug against ALS and on the reconversion of Relyvrio for other diseases.
For patients already being treated with that drug (about 3,900 in the United States), the company said it would offer them to continue for free.
“We commend Amylyx for removing Relyvrio from the market, while ensuring that people living with ALS can access the drug if they believe it is helping them,” said the American ALS Association, which had pushed for the drug’s approval and funded its approval. investigation.
Source: AFP
