New Alzheimer’s Drug Designed to Slow Disease Approved by FDA

Brain inflammation and Alzheimer’s disease. Credit: NIH Image Gallery, CC-BY-NA-2.0/FLICKR

The FDA has approved a new drug shown to slow down the early stages of Alzheimer’s despite controversy surrounding some of its more serious side effects.

Lecanemab, the first drug to actively decelerate the progress of the disease, seems to have both pros and cons. It clearly has a positive impact in the early stages, for example. Yet brain swelling and bleeding may also occur. Nonetheless, many have hailed its approval due to the number of victims Alzheimer’s continues to claim.

New Alzheimer’s drug approved by FDA

The FDA has in fact given the green light to two new drugs. The first of these is Lecanameb—otherwise known as Leqembi—and the second is Aduhelm. The two were created in conjunction by the companies Eisai in Japan and Biogen in the U.S. This means that each is able to stall, if not impede, the evolution of Alzheimer’s in its earliest stages.

Given that the disease affects 6.5 million people in the U.S., the FDA immediately placed the two drugs on its Accelerated Approval Reforms pathway. This procedure enables officials to approve drugs for serious conditions when there is an unmet medical need. Approval is granted for drugs exhibiting such effects that will reasonably likely predict clinical benefits to patients.

In a press statement released by the FDA,  the administration defended its actions, stating:

Today, the U.S. Food and Drug Administration (FDA) announced accelerated approval for Leqembi (lecanemab-irmb) for the treatment of Alzheimer’s disease. Lecanemab is made by the pharmaceutical companies Eisai and Biogen. In 2022, researchers at Biogen/Eisai published the results of a phase 3 clinical trial called Clarity-AD in The New England Journal of Medicine. The results showed lecanemab produced a clear yet modest clinical benefit in people who were in the early stages of Alzheimer’s.

Billy Dunn, M.D. and Director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, also added:

Alzheimer’s disease immeasurably incapacitates the lives of those who suffer from it and has devastating effects on their loved ones. This treatment option is the latest therapy to target and affect the underlying disease process of Alzheimer’s, instead of only treating the symptoms of the disease.

Controversial side effects

Though its approval has received accolades from many scientists, doctors, and researchers in the field, others have approached the news with more hesitancy.

“I’m of the side that it’s not perfect, but it’s a step in the right direction,” Joy Snider, a neurologist and the head of Washington University’s School of Medicine in St. Louis, stated according to the journal Science.

Maria Carrillo, chief science officer of the Alzheimer’s Association and a neuroscientist in San Francisco, also agreed that Lecanemab was “a win for all of us.”

There are those against it, however, such as neurologist Alberto Espay of the University of Cincinnati. “I think that this drug should not be approved,” Espay said in an interview prior to the FDA’s announcement of the drug’s approval. But the officials at the agency “are victims of an artificially low bar” that he believes was set in 2021 for the drug aducanumab, another medication designed to treat Alzheimer’s.

The development of Amyloid-related imaging abnormalities (ARIA) is one of the main concerns. ARIA are abnormal differences visible in magnetic resonance imaging of the brain in patients with Alzheimer’s disease. These appeared in other clinical trials testing the same type of anti-amyloid drugs targeting the disease.

Another dislike is the drug’s high price tag. It costs $26,500 a year for bi-weekly treatments with Leqembi and $56,000 a year for Aduhelm. This makes the drug inaccessible for most patients.

Two Greeks at the forefront of the new discovery

Stelios Papadopoulos, the chairman at Biogen, and Michel Vounatsos, the company’s CEO, stand at the forefront of the new discovery.

“At Biogen, we are committed more than ever to neuroscience and brain health, to pioneering science and working fearlessly to change patients’ lives,” Vounatsos stated. “Our focus remains, as always, on their unmet need.”

As for the development of the new drug, Papadopoulos maintained in an interview with Greek state broadcaster ERT that the drug’s development “is a huge, but first step in the fight against Alzheimer’s in history.”