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Wesley is rich in tradition and always looking towards the future. We welcome you to worship with us on Sunday mornings at 10am. Everyone is welcome. http://www.wumcsf.org
United Women in Faith
We will be taking a break in September from meeting for UWF at Wesley. However, there will be a district meeting Sept. 16 at First UMC in Sioux Falls (Registration $10 includes lunch). If you are interested in attending, let me know and I will let Mary Richards know you will be attending. There will be a guest speaker from REACH a literacy program. Please consider joining us for fun, fellowship, worship, and learning about REACH. They are asking that we each bring a children’s book to donate to REACH.
Alzheimer’s medication approved by the FDA
The Food and Drug Administration on Thursday approved the drug lecanemab for people with early Alzheimer’s disease, making it easier for older adults to get the first drug proven to slow memory and thinking problems.
The decision was closely watched by patient advocates and scientists alike because Eisai and Biogen’s drug, sold under the brand name Leqembi, is the first beta amyloid-targeting medication to pass the FDA’s full review. The approval also is expected to trigger Medicare coverage for adults over 65 who have been unable to afford the $26,500-a-year drug. More than 6 million Americans live with Alzheimer’s disease, the fifth-leading cause of death for adults over 65.
The drug works by clearing beta amyloid, a protein the accumulates in the brains of Alzheimer’s patients. Drug companies have pursued amyloid-targeting drugs for two decades on the theory that removing clumps of the protein from the brain could delay or halt memory and thinking problems. Eisai said its study showed people administered a biweekly infusion of the drug declined 27% more slowly than a placebo group.
FDA bolsters safety warnings
The FDA will require a boxed warning about the drug’s known side effects, which include brain swelling and tiny bleeds. These side effects, called amyloid- related imaging abnormalities, occur in some patients who take Leqembi or other amyloid-targeting drugs. While most patients won’t notice symptoms that typically surface early during treatment, some experience headaches or infusion-related reactions such as fever, chills or stomach discomfort. The safety language warns “serious and life-threatening events rarely can occur,” including strokes.
Doctors also should be cautious when prescribing the drug to patients on blood thinners, the FDA said.
Improved access
The FDA’s full approval means Medicare will pay for the drug as long as prescribing doctors participate in a registry, or a database that tracks how well the drug works. Medicare said such registries are used to learn how patients fare after taking newly approved drugs or undergoing procedures.
The drug has been limited mainly to people who can afford the full price or have qualified for a clinical trial. If Medicare extends coverage following FDA’s approval, “this really changes access of the medication to a wide group of people,” Galvin said.
Advocates hail FDA move
Joanne Pike, Alzheimer’s Association president and CEO, said the FDA’s approval means patients can access a drug that “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,” Pike said. “ 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.”
Dr. Alvaro Pascual-Leone, a professor of neurology at Harvard Medical School, said Leqembi’s approval is a “major catalyst for change” for how the doctors care for dementia patients. However, he said other treatments now being developed attack Alzheimer’s disease in other ways, such as targeting tau tangles also found in brain neurons. He added other studies show lifestyle changes can slow cognitive decline.
Dawn Armstrong, Parish Nurse
