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Pressured by patients, FDA will review an ALS drug with modest data

Leon County Judge John Cooper on June 30, 2022, in a screen grab from The Florida Channel.
Kevin Allen
ALS Association
In this photo provided by The ALS Association, representatives from the group meet with former Tennessee Congressman Phil Roe, right, in his offices on Capitol Hill in Washington on March 14, 2022. The ALS Association and other patient groups have been lobbying federal officials for over a year seeking access to an experimental drug from Amylyx Pharmaceuticals.

The agency may soon approve another drug for a deadly neurodegenerative disease based on partial data that’s being debated by experts.

The Food and Drug Administration meets this week to review a closely watched drug for ALS, or Lou Gehrig’s disease, following months of lobbying by patient groups and congressional lawmakers.

The drug from Amylyx Pharmaceuticals showed modest benefits in one small study and the FDA told the company last April to run a larger one before seeking approval.

But that delay sparked pushback from patients, their families and members of Congress.

In September the FDA reversed course and agreed to review the drug based on the single study.

Experts say it's the latest example of patients exerting political pressure to push drugs through the FDA approval process.

Click here to read more of this article from the Associated Press.