FDA approves controversial Alzheimer's drug

The FDA approved the first Alzheimer's drug in nearly 20 years. The agency's decision drew controversy following warnings from independent advisers on the treatment known as Aduhelm. Dr. Jon LaPook has more.

Video Transcript

NORAH O'DONNELL: Well tonight there's a new weapon in the fight against Alzheimer's disease. The FDA just approved a new drug to fight the major cause of Alzheimer's, despite concerns about the cost and its effectiveness. Here CBS's Dr. Jon LaPook.

JON LAPOOK: It's the first drug for Alzheimer's approved in nearly two decades. The FDA saying it is urgently needed to treat the devastating disease affecting more than six million Americans. The drug called Aduhelm clears away clumps of protein in the brain, so-called amyloid plaques that are characteristic of the disease.

JOANNE PIKE: This treatment ushers in a new era in Alzheimer's treatments, going beyond just that symptom treatment to underlying biology.

JON LAPOOK: The FDA said in a statement that the reduction in plaques is reasonably likely to predict a clinical benefit. But today's announcement is controversial because previous studies have found that reducing plaque does not necessarily help patients with Alzheimer's. Last November, Dr. Caleb Alexander was on an FDA advisory committee that voted against recommending approval. What are your objections to approval of this drug?

CALEB ALEXANDER: Well, I think the jury is still out on whether it works. And in this instance, I think that the evidence is still quite murky as to the effectiveness of this product.

JON LAPOOK: Aduhelm trials have had mixed outcomes for patients.

CALEB ALEXANDER: One trial failed and one trial was partially positive. And essentially, that leaves a great deal of explaining to do regarding what accounts for these discordant results.

JON LAPOOK: But 57-year-old Jeff Borghoff, who has been living with symptoms of Alzheimer's for six years and has been part of the clinical trials, welcomes anything that might help.

JEFF BORGHOFF: We're not giving up on this one because it's shown promise. It's shown promise in me.

NORAH O'DONNELL: And LaPook joins us now. So Jon, when is this drug the most effective?

JON LAPOOK: The thinking is the sooner the better, Nora. Remember that previous drugs that decrease amyloid in the brain haven't worked and it may just be that we're giving it too late. When you think about the fact that the FDA has approved a drug that costs $56,000, and for which it's requiring further study, it just shows you how desperate everybody is for any ray of hope in this disease that is absolutely soul-crushing.

NORAH O'DONNELL: And affects so many people. Dr. LaPook, thank you.