Experimental treatment pushed by ALS patients gets day before FDA, but agency unconvinced it works
- The Food and Drug Administration is considering the approval of an experimental treatment for Lou Gehrig's disease, despite concerns that the treatment has not been proven effective.
- ALS patients and advocates are pressuring the FDA to approve the treatment, highlighting the urgent need for new ALS treatments and the willingness of the FDA to use regulatory flexibility.
- Researchers and physicians are divided on the effectiveness of the treatment, with some arguing that it significantly slows disease progression in a subset of patients, while others believe more evidence is needed.
27 Articles
27 Articles
An experimental treatment for ALS will get its day before the FDA this week—but the agency is unconvinced it works
“FDA is the 800-pound gorilla here, and if they’re convinced that the drug doesn’t work, it’s very hard to change their minds,” Marc Scheineson, a former associate FDA commissioner who now consults for drugmakers, told the Associated Press.
Experimental treatment pushed by ALS patients gets day before FDA, but agency unconvinced it works
WASHINGTON — The Food and Drug Administration meets this week to consider approval of an experimental treatment for Lou Gehrig’s disease, the culmination of a yearslong lobbying effort by patients with the fatal neurodegenerative disease.
Experimental treatment pushed by ALS patients gets day before FDA, but agency unconvinced it works
WASHINGTON (AP) — The Food and Drug Administration meets this week to consider approval of an experimental treatment for Lou Gehrig’s disease, the culmination of a yearslong lobbying effort by patients with the fatal neurodegenerative disease.
Experimental treatment pushed by ALS patients gets day before FDA, but agency unconvinced it works
By MATTHEW PERRONE AP Health Writer WASHINGTON (AP) — The Food and Drug Administration meets this week to consider approval of an experimental treatment for Lou Gehrig’s disease, the culmination of a yearslong lobbying effort by patients with the fatal neurodegenerative disease. Those advocates still face one giant hurdle: FDA regulators say the treatment hasn’t been shown to work. In documents posted Monday, the FDA reiterated its longstanding …
FDA skeptical of experimental ALS treatment pushed by patient advocates
In this photo provided by I AM ALS, Dan Tate, right, delivers a printed petition from ALS patients and advocates to Dr. Peter Marks, left, director of the Food and Drug Administration's center for biologics at the FDA campus in Silver Spring, Md., on Dec. 14, 2022. The FDA meets this week to consider approval of an experimental treatment for Lou Gehrig’s disease, the culmination of a yearslong lobbying effort by patients with the fatal, neurodeg…
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