![]() ![]() Georges Naasan, medical director of the Division of Behavioral Neurology and Neuropsychology at Mount Sinai. “It’s complicated, and because of all these complications, we have been trying to be very thoughtful and taking our time and preparing the system for this,” said Dr. Health systems have been gearing up for broader use of the medicine. The FDA says a boxed warning is included in the prescribing information to alert patients and caregivers to the potential risks associated with these side effects. About 13% of participants in the trial experienced brain swelling or bleeding, and those risks could be higher for certain groups based on their genetics or if they take blood-thinning medications. ![]() However, the drug also comes with side effects and requires monitoring through regular brain imaging. 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.” “This gives people more months of recognizing their spouse, children and grandchildren. Joanne Pike, the group’s president and CEO. “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,” said Dr. The Alzheimer’s Association said in a statement Thursday that it welcomes the FDA’s full approval. “We hope that we will have treatments that are more efficacious.” “The treatments we have right now are just the beginning of a new era,” Honig said. “It’s not that we know it’s not good for people with moderate or severe disease it’s just that we don’t know,” said Honig, who has consulted for drug companies working on Alzheimer’s medicines.Įven for those who may benefit from the drug, Honig noted, it’s not a cure Leqembi was shown in an 18-month clinical trial to slow declines in cognitive ability and function by 27%. People with more advanced forms of the disease may not benefit from the drug, he said, and may face increased safety risks. Cleveland ClinicįDA advisers vote that lecanemab shows benefit as an Alzheimer’s treatment Lecanemab can potentially postpone the fate of those with early Alzheimer's. Lawrence Honig, a professor of neurology at Columbia University Irving Medical Center, estimates that group constitutes about a sixth of the more than 6 million Americans currently diagnosed with Alzheimer’s. The drug was approved only for people with early forms of Alzheimer’s disease, those with mild cognitive impairment or mild dementia who have been confirmed to have amyloid plaques in their brains. “Getting that insurance coverage is incredibly significant … because having a treatment is awesome, but I can’t afford to pay the $26,000 cost.” ![]() “You had this treatment at your fingertips, and suddenly you had Medicare saying, ‘Yeah, but you can’t quite get access to that yet,’ ” said Joe Montminy, 59, who was diagnosed with younger-onset Alzheimer’s in his early 50s. It costs $26,500 annually before insurance coverage. But because of an earlier coverage decision by CMS, which provides insurance coverage for many elderly people with Alzheimer’s through Medicare, the drug hasn’t been widely used. Leqembi, from drugmakers Eisai and Biogen, received accelerated approval in January based on evidence that it clears amyloid plaque buildups in the brain that are associated with Alzheimer’s disease. ![]() “This confirmatory study verified that it is a safe and effective treatment for patients with Alzheimer’s disease.” “Today’s action is the first verification that a drug targeting the underlying disease process of Alzheimer’s disease has shown clinical benefit in this devastating disease,” Teresa Buracchio, acting director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, said in the announcement. The Centers for Medicare and Medicaid Services said Thursday that it will now expand coverage of the drug, broadening access for up to an estimated million people with early forms of the disease. The US Food and Drug Administration on Thursday granted traditional full approval to the Alzheimer’s drug Leqembi, the first medicine proven to slow the course of the memory-robbing disease. ![]()
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