Amylyx Pharmaceuticals will pull back its amyotrophic lateral sclerosis (ALS) medication – its sole product in the market – from the U.S. and Canada following the failure of the treatment in an important late-stage trial.
The pharmaceutical company also announced on Thursday a 70 percent reduction in its workforce. It had 384 full-time employees at the end of 2023.
Why it's important
The ALS medication, known as Relyvrio, was authorized in 2022 after advocacy from patient groups who highlighted limited options to address the potentially deadly disease.
ALS leads to gradual paralysis and death, and impacts about 60,000 people in the U.S. and Europe.
Context
The approval came after an unusual change of heart by the U.S. Food and Drug Administration’s advisors. They endorsed the medication months after initially rejecting it due to a lack of “convincing” data.
The authorization was based on mid-stage trial data in 137 patients that demonstrated the treatment slowed the progression of the disease and prolonged life expectancy.
However, a larger late-stage study failed to verify the reported benefit of slowing disease progression, showing no significant difference in patients treated with Relyvrio and those given a placebo.
By the numbers
The medication, which has a listed price of USD$158,000 per year in the U.S., generated sales of about $381 million in 2023.
Amylyx expects to face expenses of about $19 million as part of its restructuring, set to be completed by the end of the third quarter.
Shares plummeted by about 83 percent and over $1 billion was erased from its market value on March 8 after the company revealed it was contemplating withdrawing the treatment.
What's next
The company will continue trials of its primary experimental medication AMX0035 for the inherited condition Wolfram syndrome and the neurological disorder progressive supranuclear palsy. It will also concentrate on AMX0114 in ALS.
