Alzheimer’s drug Leqembi given full FDA approval
Alzheimer’s drug Leqembi has full FDA approval
U.S. officials have granted full approval to a closely watched Alzheimer’s drug for patients with early stages of the disease. The Food and Drug Administration decision clears the way for Medicare and other insurers to begin paying for the drug called Leqembi.
NEW YORK - The FDA granted full approval to a closely watched Alzheimer’s drug on Thursday, clearing the way for Medicare and other insurance plans to begin covering the treatment for people with the brain-robbing disease.
The Food and Drug Administration endorsed the IV drug, Leqembi, for patients with mild dementia and other symptoms caused by early Alzheimer's disease. It’s the first medicine that’s been convincingly shown to modestly slow the cognitive decline caused by Alzheimer's.
"It brings me so much hope," said Zelik Bocknek.
Bockneck has early-onset Alzheimer’s disease, and is now being treated with Leqembi.
Medical professionals treating Alzheimer's are calling the drug a real breakthrough.
"This drug, this antibody, acts to clear these toxic proteins from the brain, thus hopefully lead cognitive benefits and patients," said Dr. Thomas Wisniewski, Director of the Alzheimer's Disease Center at NYU Langone Health. "This is a very exciting development for the Alzheimer's disease field and Alzheimer’s patients as this is the first fully approved FDA drug. That's disease-modifying for Alzheimer’s disease. So it's a milestone for the field."
The drug is only approved for patients with mild dementia and other symptoms caused by early Alzheimer’s disease.
David German cared for his wife Linda who was diagnosed with early-onset Alzheimer's when she was just 61. He cared for her for more than a decade before she died at the age of 72 of the disease.
"If this drug works and glad it was okayed by the FDA I know they look into these things i think it's a big step forward and it's a great step forward for all those with no options for all these years," German said.
In a statement, the Alzheimer’s Foundation of America said:
"We are encouraged that the FDA’s traditional approval will make a positive difference in the lives of individuals and families affected by Alzheimer’s disease. Progress is being made in the fight against Alzheimer’s disease, but we must continue moving forward until the finish line of finding a cure for Alzheimer’s disease is reached. Patient access and affordability to all of those in need is vitally important, as with any medication, and we hope the FDA’s actions will facilitate both. We strongly urge federal policymakers to continue increasing investments in Alzheimer’s disease research and caregiver support services to deliver help today and hope for the future to the more than 6 million American families affected by Alzheimer’s disease."