CHARLOTTE, N.C. — The FDA traditionally approved drug lecanemab, marketed as Leqembi, is giving families hope for a longer life with loved ones diagnosed with Alzheimer’s disease. 

The FDA granted traditional approval to the drug on July 6, 2023. According to the Alzheimer’s Association, this is the first one of its kind that changes the underlying course of the disease.

What You Need To Know

  • Lecanemab is the first treatment traditionally approved by the FDA that changes the underlying course of Alzheimer's
  • The drug is meant for people with mild cognitive impairment, or those in the early stages of the disease
  • Centers for Medicare & Medicaid Services are covering the drug, making it more accessible to families

“This is game changing,” said Kathrine Lambert, Alzheimer’s Association Western Carolina Chapter CEO. “Hopefully now, people see hope, people see potential treatment. But, the only way to benefit from these drugs that are coming is earliest detection and accurate detection.”

In a clinical trial, Leqembi delayed cognitive decline by 5.3 months compared to a placebo over an 18-month period. It’s a twice monthly IV infusion that works by targeting amyloid beta, and is intended for people in the early stages of the disease.

The same day lecanemab received FDA traditional approval, the Center of Medicare & Medicaid Services (CMS) announced its plan to enable coverage to FDA traditionally approved Alzheimer’s treatments. Without coverage, the drug is an out-of-pocket cost of more than $25,000 a year.

“This drug is going to be accessible to those who have the testing and the accurate biology that this drug will benefit,” Lambert said.

This accessibility is something the local Alzheimer’s Association chapter rallied for. 

Husband and wife, Jeff and Penny Lambert, were at that rally. Jeff Lambert was diagnosed with mild cognitive impairment in 2018, and then diagnosed with early-onset Alzheimer’s disease in 2020. He was 56 years old. 

“I had to retire,” said Jeff Lambert. “Basically, Penny said, ‘I’m stopping too. We’re going to spend the rest of our lives together.’”

Jeff Lambert is in a different clinical trial for a drug targeting Alzheimer’s, but he and Penny say they are still interested in seeing if lacanemab is a drug that will work for them. Accessibility to the drug, with the help of insurance, now makes that tangible. 

Lambert says it’s a victory for this specific drug, but there is more to do when it comes to CMS covering other Alzheimer’s treatments.

“The overall national coverage determination for this class of drugs has not been lifted, and we have worked very hard and will continue to work so that all FDA approved drugs that folks can benefit from will be covered and be available,” said Lambert.