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
But the reviewers found the drug had “only a modest” effect on slowing the disease's progression in a 137-patient, mid-stage study, which reviewers said was plagued with implementation and analysis problems. Typically, FDA approval requires two large studies or one study with a “very persuasive” effect on survival.
After further discussions with regulators last summer, Amylyx decided to submit its drug for approval based on the initial study plus survival data gathered afterwards. The company said that data showed patients who took the drug lived about six months longer than those taking a dummy drug. Wednesday's meeting marks the first time FDA has convened this advisory panel since disregarding its advice last June and approving Biogen’sAlzheimer’s drug, Aduhelm. Three panel members resigned over the controversial decision and congressional investigators launched a probe into FDA’s handling of the drug’s review. As in the current case, the FDA faced intense pressure from patient groups to grant approval.
The ALS Association, which helped fund Amylyx’s research, said the FDA’s review does not take into account “the speed and severity of ALS and the few treatment options available.”
Canada Latest News, Canada Headlines
Similar News:You can also read news stories similar to this one that we have collected from other news sources.
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 »
Nationwide recall of Milk of Magnesia due to possible bacterial contamination: FDAThe popular over-the-counter product for heartburn and constipation could cause intestinal distress instead if it's from the contaminated lots.
Read more »
Nationwide recall of Milk of Magnesia due to possible bacterial contamination: FDAThe popular over-the-counter product for heartburn and constipation could cause intestinal distress instead if it's from the contaminated lots.
Read more »
ABC News: FDA could authorize second booster shots for Americans over 50 this weekTwo officials familiar with the matter tell ABC News the FDA could authorize second booster shots for Americans over 50 years old as soon as Tuesday, but the details are still under discussion.
Read more »
Milk of Magnesia products being recalled over possible contamination, FDA saysMilk of Magnesia products and other medications are being recalled over possible contamination, according to the Food and Drug Administration.
Read more »