A panel of outside advisers to the US Food and Drug Administration on Wednesday (Mar 30) voted against approving Amylyx Pharmaceuticals' drug for amyotrophic lateral sclerosis (ALS), a neurodegenerative disease.
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The committee voted 6 to 4 against the oral drug, AMX0035, saying the company's clinical study data failed to establish that it was effective against the disease.
Amylyx's FDA submission was based on a 24-week placebo-controlled study of 137 participants with ALS.
ALS, whose cause is largely unknown, leads nerve cells in the brain and spinal cord to break down, affecting physical function and resulting in severe disability and death.
Commonly known as Lou Gehrig's disease, ALS entered the spotlight in 2014 due to the "Ice Bucket Challenge", which involved people filming themselves pouring ice-cold water over their heads to raise awareness.
The FDA's decision on the drug is expected by Jun 29. The agency typically follows the panel's recommendations, though it is not obligated to.
The panel's decision was in line with briefing documents released on Monday, where the FDA staff reviewers raised concerns over the drug's trial data and efficacy.