FDA approval of Alzheimer’s drug ‘a turning point’

ROCHESTER, N.Y. — In a scientific breakthrough in the fight against Alzheimer’s disease, the Food and Drug Administration has given traditional approval to medication called Leqembi.

It was given accelerated approval back in January — but after getting the full-fledged green light Thursday, Leqembi is now the first FDA-approved medicine that treats the cause of Alzheimer’s.

“When my dad was diagnosed in 2008, there were no treatments. and so, 15 years later to see that we have two treatments that have been approved, that really gives you hope,” said Matthew Mann.

Mann is a board member for the Alzheimer’s Association’s Rochester chapter. His father, Chuck Mann, died in 2018 after living with the degenerative, memory-stealing disease for 10 years.

“When you talk to doctors, they basically would tell you enjoy the time that you have, because there’s really — there was nothing at that time they could do,” Mann said.

But now, that’s not the case for those diagnosed early on. Experts say that this new drug may give those in the early stages of Alzheimer’s a little more time, according to Dr. Anton Porsteinsson, who oversees the University of Rochester Medical Center’s Alzheimer’s research.

“This is different than the medications that we’ve had historically available for Alzheimer’s disease,” said Porsteinsson, who participated in Leqembi research. He says that the drug was found to slow the cognitive decline in an early stage Alzheimer’s patient by 25 to 40%.

“When you look at somebody getting diagnosed at 70, 80, 90 years old — five months doesn’t seem like that long, but in those five months so much can happen,” said Kristen Merlin, director of community engagement with the Alzheimer’s Association.

Porsteinsson said the drug isn’t a cure-all. it can’t stop or reverse cognitive decline, and it’s only for those in the early stages.

However:

“Tthis is a turning point in history in the fight against the disease. And i think it’s definitely a step in the right direction. There’s a lot more to be done but definitely a step in the right direction,” Merlin said.

The drug is not a silver bullet. it comes with a hefty $26,000 price tag, and requires bi-weekly trips to the hospital for injections — and Porsteinsson says it does have side effects that caused temporary brain swelling for about 12% of patients.

But for the first time, it provides those diagnosed with an option.

For Matthew Mann, a treatment like this shows the possibility for a cure. But it also shows that right now, the diagnosis can be a little less scary for some.

“If you are diagnosed early, now we know that there is hope, that you can have this treatment. and it may extend a person’s life, extend their quality of life. and i think that’s really important,” Mann said.

Everyone I spoke to today said this new drug represents the tip of the iceberg in Alzheimer’s research. There are new drugs and new breakthroughs coming down the pipeline as early as next year.