Newly Approved Drug Offers Hope for Alzheimer's Patients

The U.S. Food and Drug Administration (FDA) recently announced that it has granted full regulatory approval to a new drug being used to treat patients with Alzheimer’s disease. While other approved drugs only target its symptoms, Leqembi^TM (lecanemab) is the first one that actually slows progression of the disease, the FDA notes.

Alzheimer’s is a degenerative brain disease and the most common form of dementia, according to the Alzheimer’s Association. Roughly 6.7 million U.S. adults ages 65 and older have Alzheimer’s and an estimated 55 million people worldwide are living with the disease and other forms of dementia.

Leqembi, a monoclonal antibody manufactured by Japanese drugmaker Eisai and U.S.-based drugmaker Biogen, targets beta-amyloid, a type of protein in the brain thought to be one of the underlying causes of Alzheimer’s disease. Studies based on a phase 3 clinical trial of 1,795 patients with mild cognitive impairment or early-stage disease showed progression of the illness was slowed by 27 percent over an 18-month period.”

Leqembi is the first medication other than Aduhelm (aducanumab) to be approved for the treatment of Alzheimer’s disease in many years. Aduhelm was approved by the FDA in 2021 for the treatment of certain symptoms of Alzheimer’s disease and other forms of dementia. Experts say Leqembi offers hope for those who either have the disease or have loved ones who have been diagnosed.

Raphael Wald, Psy.D., neuropsychologist with Marcus Neuroscience Institute at Boca Raton Regional Hospital

Raphael Wald, Psy.D., a neuropsychologist with Marcus Neuroscience Institute at Boca Raton Regional Hospital, part of Baptist Health, says the newly approved drug “provides hope.” It also offers confirmation that monoclonal antibody therapy can be effective, he says. “Monoclonal antibody therapy treats the abnormal bodies associated with Alzheimer’s as if they’re invaders, like viruses,” he explains. “It targets them, attacks them and breaks them up.”

Dr. Wald says that people must be diagnosed with Alzheimer’s disease in order to be treated with Leqembi, which is administered every two weeks by IV infusion. “We’re currently working on the best possible protocol at Marcus Neuroscience Institute to administer Leqembi infusions to people with Alzheimer’s,” he says, adding that those with early Alzheimer’s disease are most likely to benefit from the drug.

The Alzheimer's Association, which has vocally advocated for the drug's approval, praised the decision. Joanne Pike, president and CEO of the Alzheimer’s Association, said in a statement that the newly approved treatment could “give people in the early stages of Alzheimer’s more time to maintain their independence and do the things they love.”

Concern over possible side effects were part of the reason for the FDA’s lengthy review of Leqembi, which can lead to side effects including “bleeding and swelling of the brain,” according to data from clinical trials. Patients being treated with the drug need to be closely monitored, with regular MRIs to check for bleeding and swelling, Dr. Wald says.

The FDA’s approval of Leqembi brings the world closer to a cure for Alzheimer’s disease, says Dr. Wald. “There is a great deal of Alzheimer’s research being done,” he says. “One particularly promising approach has been to open the blood-brain barrier in order to allow Alzheimer’s abnormalities to escape. More research will bring us ever closer to finding ways to prevent and reverse this disease.”