The FDA has posted another negative review of a closely watched drug for the deadly neurodegenerative disease ALS.
regulators remain unconvinced about the benefits of a closely watched experimental drug for the debilitating illness known as Lou Gehrig’s disease, even as they prepare to give its drugmaker a rare second opportunity to make a public case for the treatment.
In March, the same panel of neurological experts voted 6-4 that the company’s data failed to show a convincing benefit for ALS, or amyotrophic lateral sclerosis. It’s extremely rare for the FDA to call a second review meeting after its advisers have already voted. ALS destroys nerve cells needed to walk, talk, swallow and — eventually — breathe. There is no cure and most people die within three to five years.
Amylyx’s data comes from one small, mid-stage trial that showed some benefit in slowing the disease, but which was marred by missing data, implementation errors and other problems, according to FDA reviewers. The FDA does not publicly explain its rationale for holding meetings. But some outside analysts believe the agency is hoping that more external input will strengthen its hand when it renders its final decision, expected by the end of the month.
The FDA will hear again from patients and advocacy groups, such as I AM ALS, which has lobbied the FDA and Congress for more than two years to make the drug available. The group’s founder, Brian Wallach, said ALS patients, physicians and researchers believe that the company’s data warrants approval.
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