First Alzheimer’s Drug Gets the FDA Nod for Slow Release

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pathdoc /

July 6th marked a turning point on the road to treating Alzheimer’s.

As the first drug to ever received Food and Drug Administration (FDA), Leqembi could prove to be something really special. Coming from drugmakers Eisai and Biogen, the medication first received accreditation from the FDA in January. The accreditation is based on evidence that the drug would clear amyloid plaque buildups in the brain that are associated with Alzheimer’s disease.

However, the Centers for Medicare and Medicaid Services had previously ruled on the drug non-favorably, this decision kept the drug sky high at $26,500 per month. Far beyond the means of most Americans, and high enough most insurance plans would not cover it.

Now CMS has reversed its decision in light of the full approval, and expansion of the use of the drug is expected almost immediately.

According to Dr. Lawrence Honig, a professor of neurology at Columbia University Irving Medical Center, over a sixth of Americans could benefit from the drug. It is currently being approved for early forms of Alzheimer’s disease, mild cognitive impairment, and mild dementia when they have confirmed amyloid proteins in their brains. However, he cautioned that they don’t know how it will impact those with moderate or severe forms of the disease.

Honig cautions that we are just at the start of a new era in medicine, and he as well as many others, remain hopeful that this will lead to treatments for moderate and even severe dementia.

Dr. Joanne Pike, president and CEO of the Alzheimer’s Association, welcomed the FDA’s full approval in a statement on July 6th.

“This treatment, while not a cure, can give people in the early stages of Alzheimer’s more time to maintain their independence and do the things they love. This gives people more months of recognizing their spouse, children, and grandchildren. This also means more time for a person to drive safely, accurately, and promptly take care of family finances, and participate fully in hobbies and interests.”

Mind you, it’s not a drug without risks. 13% of the nearly 1800-person testing group who used the drug experienced brain swelling or bleeding. This is a significant risk for people to be worrying about, especially with the way the disease progresses.

Thankfully, with it being administered every two weeks via IV, the infusion centers for this kind of treatment are often located in areas near imaging centers. This could help ensure swelling and bleeding of the brain can be quickly treated.

CMS administrator Chiquita Brooks-LaSure issued a statement about the changes going on, and how CMS is working to quickly respond and help.

“CMS today affirms our commitment to help people with Alzheimer’s disease have timely access to innovative treatments that may lead to improved care and better outcomes. With FDA’s decision, CMS will cover this medication broadly while continuing to gather data that will help us understand how the drug works. This is welcome news for the millions of people in this country and their families who are affected by this debilitating disease.”

This isn’t going to be a path to perfection for Alzheimer’s patients. There are still a lot of unknowns about drug interactions, and the CMS system is still a joke for getting payments for treatment handled. However, it is on the right path, and they are working towards making this easier.

One big question about this is how President Biden is tied in with these efforts.

The American people have long hypothesized that sleepy Joe is getting Alzheimer’s and, given how little advancement in the disease was accomplished before he got into the White House, the timing is funny. Especially as he is gearing up for more public appearances on the cusp of the 2024 elections.