Understanding the Alzheimer's Rx Approval Controversy

Approval of Alzheimer's Rx Aduhelm (aducanumab) stirs up controversy

(RxWiki News) On June 7, the US Food and Drug Administration (FDA) gave the green light for an Alzheimer's disease treatment. That may sound like good news, but the approval has stirred up controversy.

The last time a treatment for Alzheimer's disease was approved was in 2003. Now, 18 years later, the FDA has finally approved a new Alzheimer's treatment under the name Aduhelm (aducanumab). While some are celebrating this approval, the decision has come with some controversy and criticism.

For starters, the FDA approved this treatment against the recommendation of its own advisory panel not to approve it.

And since the approval, three experts have resigned from an FDA advisory committee.

One of those experts, Dr. Aaron Kesselheim, a professor at Harvard Medical School, called the FDA move "probably the worst drug approval decision in recent U.S. history" in a resignation letter he sent to the the acting FDA commissioner.

One of the concerns with Aduhelm is that this drug was approved as a treatment for all Alzheimer’s patients regardless of their stage. However, the drug was only studied in those who had mild Alzheimer's disease and tested positive for beta amyloid plaques, yet the drug label was approved without any restrictions — at least at first.

After a few weeks of ongoing controversy and criticism tied to this approval, the FDA is now restricting the use of aducanumab to patients with milder forms of Alzheimer’s. The update to the drug label restricting the use to those with mild Alzheimer’s is now aligned with the population in which the drug was studied.

Despite this controversy, a recent survey found that doctors were showing some interest in prescribing aducanumab. Analysts surveyed 50 US neurologists and psychiatrists who were treating about 12,000 Alzheimer’s patients. The survey showed interest in prescribing Aduhelm for about 35 percent of early-stage Alzheimer’s patients with mild cognitive impairment.

Another early concern about Aduhelm was the cost of this treatment option. This infusion had a price tag of $56,000 per year, according to NPR.

This treatment is available as an injection and is to be administered into the vein for one hour every four weeks.

The FDA granted this approval to Biogen via the accelerated approval pathway.

If you or a loved one has Alzheimer's disease, speak with your doctor about the available treatment options.