What wonderful news.
For the first time, the FDA fully approved a drug to treat Alzheimer’s, “which slowly destroys memory and thinking skills and eventually, the ability to carry out simple tasks.”
Leqembi is a drug that can slow the progression of Alzheimer’s. The FDA conditionally approved the drug in January.
The agency moved it to “traditional approval following a determination that a confirmatory trial verified clinical benefit.”
Considering it’s a devastating disease, it doesn’t shock me that people asked to try the medicine during the testing period:
The Food and Drug Administration on Thursday granted full approval to Leqembi, allowing Medicare enrollees to get fully covered treatment with the drug if they qualify and agree to report data to a registry. Most of the six million people in the U.S. with Alzheimer’s are eligible for Medicare.Eisai, which developed the drug with Biogen, said Leqembi could generate $7 billion in annual sales globally by 2030.Clinics said they have been flooded with queries from patients eager to use Leqembi despite safety concerns. But adoption will be limited by shortages of doctors and specialty centers that are best equipped to prescribe the drug, neurologists said.Leqembi, which the FDA conditionally approved in January but Medicare didn’t widely cover, is part of a class of Alzheimer’s drugs that target amyloid, a sticky plaque in the brain that some researchers think plays a role in driving the disease. It is the first anti-amyloid treatment the FDA has fully approved and the first to clearly slow cognitive decline in patients with early Alzheimer’s.
I’m not one who thinks a patient should have to wait for the FDA to approve a drug. I have rheumatoid arthritis, lupus, and Sjögren’s syndrome. If I could try a new medicine, I’d say, “Sign me up!”
Thank goodness Medicare will cover it. If you’re going to force people to use Medicare, then cover the dang medicine they could need.
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