SHOLEH: New Hope for Alzheimer's

For folks with early-stage Alzheimer’s, hope is on the horizon. A drug newly approved by the Food and Drug Administration may help slow its progression.

According to the Alzheimer's Association, more than 6.5 million Americans have Alzheimer’s, an irreversible, progressive brain disorder which slowly destroys memory and thinking skills. About one in nine age 65 and older (10.7%) has Alzheimer's. While symptoms most often show in people over 60, data indicate that its workings in the brain can start as early as age 30 and, rarely, even in the 20s.

Almost two-thirds of Americans with Alzheimer's are women. Deaths from Alzheimer’s have more than doubled between 2000 and 2019, while those from heart disease — the leading cause of death — have decreased. By 2050, the number of people 65 and older with Alzheimer’s is projected to reach 12.7 million, barring a medical breakthrough to prevent, slow or — dare we hope — cure it.

Friday, the FDA approved Leqembi, a monoclonal antibody drug which targets Alzheimer’s fundamental pathophysiology. What distinguishes it from other drug therapies is that it targets the underlying disease process, instead of only treating symptoms, according to an FDA statement.

In a double-blind, placebo-controlled study of 1,795 patients aged 50-90 with mild-stage Alzheimer’s, researchers found that those who got Leqembi had significant dose- and time-dependent reduction of amyloid beta plaque. That’s the stuff coating the brains of Alzheimer’s patients which essentially causes brain cells to die, so the less, the better. The drug was administered biweekly through IV-infusion.

The 18-month clinical trial published in the New England Journal of Medicine last week involved a large array of scientists, but was co-written by some from the drug’s production company. That’s not unusual, but even company representatives emphasized the need for more studies. Next up are more clinical trials of the recently approved Leqembi, the brand name for lecanemab, to determine its efficacy and safety.

Japanese pharmaceutical company Eisai led the drug’s development and testing. Eisai is partnering with the American company Biogen, maker of the controversial Alzheimer’s drug Aduhelm, for Leqembi’s American license and the companies will split the profits equally.

Eisai said the list price for Leqembi (pronounced le-KEM-bee) would be $26,500 per year per patient. Some physicians and advocates are already expressing concern about that, given the growing number of patients with the disease, which cost the nation $321 billion in 2022 according to the Alzheimer’s Association.

The Leqembi label says the drug should be used only for patients in the early and mild stages of Alzheimer’s like those in the study, at least until more is known.

What all this will actually mean in a patient’s day-to-day life, let alone the long-term picture, remains to be seen. Still, for those families facing a future of progressive Alzheimer’s, hope means a lot.

• • •

Sholeh Patrick is a columnist for the Hagadone News Network. Email sholeh@cdapress.com.