ALS Drug Relyvrio Removed from US Market After Trial Failure!
United States: An organization that has been producing a medication that treats Lou Gehrig’s disease recently showed that the drug does not work on a big sample of individuals, and so on Thursday, the company decided to announce that they would release the medication in the market.
Amylyx Pharmaceuticals made it known that the pharmaceutical company would call off its distribution and marketing in the US and Canada, with new patients not eligible to get the prescription anymore.
As per the statement from the company’s co-founder, “While this is a difficult moment for the ALS community, we reached this path forward in partnership with the stakeholders who will be impacted and in line with our steadfast commitment to people living with ALS,” as ABC News reported.
Furthermore, those who have already been executing this therapy may as well qualify for the program that allows them to get this drug for free.
The FDA availed a new drug in the market in September 2022 following a long and drawn-out campaign by ALS patients and their supporters, which targeted its approval.
Disappointment to ALS patients
According to ABC News reports, it is a real bitter loss for patients and advocates, who demand the FDA and other authorities to fund and authorize experimental therapies for this fatal muscle-wasting disease.
Moreover, the withdrawal of Rekyvrio from the market has left patients with ALS with three medicines that are available in the US, out of which just one has shown positive results of extending the survival rate by several months.
Laying off employees after the move
Even the biotech company Amylyx, headquartered in Cambridge, Massachusetts, announced yesterday it will lay off 70 percent of its over 350 employees as the company is part of a major restructuring effort.
Moreover, corporate executives stated that besides Relyvrio, there is another recorded drug that is being studied by the company for connection with several rare diseases, such as Wolfram syndrome, which leads to childhood diabetes and blindness.
About the failed clinical trial
Amylyx reported last month that it had named the drug pulling after a trial with about 600 people, but it had not shown any improvements in survival or other health variables, including muscle strength or walking ability, ABC News reported.
The company’s decision by itself prevents the FDA from being in front of a serious complication. The US FDA’s regulators would not have had a clear path to immediately withdraw the drug from the market except for the ethical and kind approach taken by the company, which led to the withdrawal of the product. Hence, the case in which the FDA granted the vaccine full approval is not proven by its initial data on its effectiveness.