FDA Backs Up Aduhelm Approval, Now Says Only Early Alzheimer’s Patients Should Get It

The Food and Drug Administration amends its recent and controversial approval of a new drug for Alzheimer’s disease. The agency now recommends that the drug, called Aduhelm and developed by Biogen, should only be administered to persons in the early stages of ultimately fatal neurodegenerative disease. The decision will greatly influence the insurance coverage of the treatment, which is expected to cost $ 56,000 per year.

The move comes barely a month after the agency first approved the drug against the recommendations of an external panel which examined evidence from clinical trials. Since then, researchers and legislators have critical the FDA, with some calling the approval the worst such decision in recent history.

Among other things, critics have sharp lackluster data supporting Aduhelm’s benefits, with only one trial finding statistically significant evidence of slower cognitive decline in patients, and only in those who took the highest dose (the second trial did not find a slower overall decline but perhaps an insignificant effect in high-dose patients).

Another major criticism of the FDA approval concerned the drug’s eligibility. Although it has only been tested for people with mild cognitive impairment or an early suspicion of Alzheimer’s disease, the FDA initially indicated that it would be recommended for any patient, regardless of the condition. course of his disease. has been. Language fed fears that the widespread use of drug would overwhelm public payers like Medicare, which provides health coverage to the majority of the estimated 5 million Americans currently lliving with Alzheimer’s disease. Now the FDA is withdrawing its overall approval.

“Since the agency approved Aduhelm, prescribers and other stakeholders have expressed confusion over the target population for treatment,” FDA spokesperson Michael Felberbaum Told the New York Times.

In his now updated label on the drug’s prescription, the FDA recommends that Aduhelm be “initiated in patients with mild cognitive impairment or mild dementia stage of the disease, the population in which treatment was initiated in clinical trialsls. ” According to the NYT, the FDA requested the change, Biogen agreeing to submit revised wording. Previously, the company claimed it would only market the drug to patientsrly Alzheimer.

Doctors are allowed to prescribe off-label drugs, which means that patients with more advanced Alzheimer’s disease can still have access to Aduhelm. But it’s almost certain that the new labeling will be widely adopted by insurance companies and payers like Medicare to determine cover for Aduhelm.

The move will not resolve the controversy over the drug’s approval, which some scientists fear will discourage the search for other potentially more effective treatments. More recently, STAT News has reported on a long-standing collaboration between some FDA officials and Biogen before and during the approval process, which included discussions to submit the drug through a less rigorous approval path. In response, lawmakers such as Rep. Katie Porter (D-CA) have called for a formal investigation into the FDA by the Office of the Inspector General, a government watchdog.