FDA is skeptical of benefits from an experimental ALS drug
On Wednesday, a panel of FDA advisers is scheduled to take a nonbinding vote on whether the drug from Amylyx Pharmaceuticals should be approved.
The Food and Drug Administration has issued a negative review of a closely watched experimental drug for the debilitating illness known as Lou Gehrig’s disease.
The review comes ahead of a meeting scheduled for Wednesday for outside experts to vote on the drug for ALS.
The drug has been the focal point of a lobbying campaign by patients, their families and lawmakers.
FDA reviewers said Monday the single study from Amylyx Pharmaceuticals was “not persuasive” due to missing data, errors in enrolling patients and other problems.
Additionally, regulators were not convinced by data that the company said showed the drug helped patients live six months longer.