The newest 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 authorized medication that doesn’t seem to work.
Amylyx Prescribed drugs’ announcement Friday that its drug, marketed as Relyvrio, failed to beat placebo in a pivotal study marks “a tragic day for us, however we now have to imagine the info,” mentioned Mary Catherine Collet, an ALS advocate. “These are onerous scientific info that we now have to face, and I respect that they’re not making an attempt to spin us like some cheerleading observe.”
The query now’s whether or not Relyvrio, authorized in 2022, must be faraway from the market fully — and whether or not the Meals and Drug Administration made a mistake by authorizing it in 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.