The most recent disappointment in amyotrophic lateral sclerosis analysis introduced crushing information for sufferers and physicians, forcing the neighborhood to think about simply what to do with an accepted drugs that doesn’t seem to work.
Amylyx Prescription drugs’ announcement Friday that its drug, marketed as Relyvrio, did not beat placebo in a pivotal research marks “a tragic day for us, however we now have to consider the info,” mentioned Mary Catherine Collet, an ALS advocate. “These are exhausting scientific info that we now have to face, and I respect that they’re not attempting to spin us like some cheerleading follow.”
The query now could be whether or not Relyvrio, accepted in 2022, must be faraway from the market completely — and whether or not the Meals and Drug Administration made a mistake by authorizing it within the first place. After years of stress from affected person advocates, the company has taken a extra versatile method to medicines for devastating, incurable ailments like ALS. However the case of Relyvrio, which made $381 million in gross sales and $49 million in revenue for Amylyx final 12 months, has underlined questions in regards to the limits of regulatory leniency.
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