Federal health advisers have narrowly ruled against an experimental drug for the debilitating illness known as Lou Gehrig’s disease
FILE - A sign for the Food and Drug Administration is seen in Silver Spring, Md., on Thursday, Dec. 10, 2020. On Wednesday, March 30, 2022, federal health advisers narrowly ruled against an experimental drug for the debilitating illness known as Lou Gehrig’s disease, a potential setback for patient groups who lobbied for the medication’s approval.
Fischbeck and other panelists said they hoped results of a larger study now underway would provide more evidence. ALS destroys nerve cells in the brain and spinal cord needed to walk, talk, swallow and — eventually — breathe. There is no cure and most people die within three to five years of their first symptoms.
Dr. Teresa Buracchio, an FDA division director, said the agency had “benefitted enormously” from patients' input. But she added that the problems with Amlyx's drug exist “even with the recognition that ALS is a rare disease, with a relentless course that has an enormous unmet medical need.” But FDA scientists said those results were “not persuasive” because of missing patient data, study conduct errors and unrealistic assumptions about how patients would decline over time.“I went back and forth during the day but ultimately I agreed with the primary analysis,” said Dr. Dean Follman, a biostatistician with the NIH.
Ireland Latest News, Ireland Headlines
Similar News:You can also read news stories similar to this one that we have collected from other news sources.
FDA advisers to review ALS drug funded by Ice Bucket ChallengeAdvocates are pushing for a positive recommendation from the panel, but a review by FDA scientists said data was lacking on the drug's effectiveness.
Read more »
ALS drug funded by Ice Bucket Challenge to be reviewed by FDAAdvocates are pushing for a positive recommendation from the panel, but a review by FDA scientists said data was lacking on the drug's effectiveness.
Read more »
FDA skeptical of benefits from experimental ALS drugThe 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.
Read more »
FDA skeptical of benefits from experimental ALS drugThe 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.
Read more »
FDA skeptical of benefits from experimental ALS drugThe drug from Amylyx Pharmaceuticals has become a rallying cause for patients with the deadly neurodegenerative disease ALS, their families and members of Congress who’ve joined in pushing the FDA to greenlight the drug.
Read more »
FDA skeptical of benefits from experimental ALS drugThe 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
Read more »