FDA grants approval for Alzheimer’s treatment drug
Denise Galloni is relieved that the U.S. Food and Drug Administration (FDA) has granted traditional approval to the drug sold under the brand name Kisunla for treatment of Alzheimer’s disease, the most common type of dementia.
It would not have helped her mother, Sylvia Goodfellow, who was diagnosed a little more than a year before passing in 2023.
“But it’s really going to help these family members when they learn that someone who has dementia will have some more time and have a better quality of life,” Galloni said. “We didn’t have that with my mother because she was pretty far along. We couldn’t talk to her about what she wanted to do with the rest of her time, hear stories from her past and learn things about her. We didn’t have that chance; it was taken away from us.”
Kisunla is used to treat adults living with early symptomatic Alzheimer’s disease, which includes mild cognitive impairment and the mild dementia stage of Alzheimer’s disease. According to information from the Alzheimer’s Association, Kisunla slowed cognitive and functional decline by up to 35% compared to a placebo at 18 months during a pivotal study and reduced participants’ risk of progressing to the next clinical stage by up to 39%.
Kisunla can’t reverse or stop existing memory or thinking issues that are due to early symptomatic Alzheimer’s disease, but it can slow the progression of the issues.
Kisunla marks the third drug approved by the FDA for Alzheimer’s treatment; Aduhelm was approved in 2021 and Leqembi, 2023.
“This is real progress,’ said Dr. Joanne Pike, Alzheimer’s Association president and CEO. “Having multiple treatment options is the kind of advancement we’ve all been waiting for – all of us who have been touched, even blindsided, by this difficult and devastating disease.”
Galloni, of Bethel Park, knows the toll the disease can take on the caregiver and having the use of a drug like Kisunla available can make their lives a little easier.
“It was tough,” she said. “We didn’t even realize she had dementia until she was diagnosed. It came out of the blue. A couple months later, she didn’t know who we were. She was going back to her childhood, traumas that she had in her childhood. She was asking for her parents. It was really difficult. She didn’t think there was anything wrong with her. For her, she was just acting normal. Having someone not know who you are, having someone’s personality change and argue with you all the time was the complete opposite of what she was.”
Her mother, also from Bethel Park, raised Galloni and her sister, Donna Goodfellow, on her own after Galloni’s father, Robert Goodfellow, died in 1974.
“She devoted her life to taking care of my sister and I,” Galloni recalled. “She was Wonder Woman.”
Nearly 7 million Americans are living with Alzheimer’s disease, a leading cause of death in the United States. Additionally, more than 11 million family members and friends provide care to people living with Alzheimer’s and other dementias.
In Pennsylvania alone, there are more than 280,000 people living with Alzheimer’s and more than 465,000 family members and friends caring for them.
Galloni wants to continue the quest to raise money in fighting the disease and one day finding a cure for all dementias.
She plans to continue her involvement with the Washington Walk to End Alzheimer’s, which is scheduled for Oct. 5 at the Hollywood Casino at the Meadows. Already 47 participants and 16 teams have signed up to participate and $42,306 of the goal of $95,000 has been raised.
“I am walking again this year,” Galloni said. “It’s very fulfilling to know that I can contribute to this so eventually we do have a cure to this horrific diagnosis of Alzheimer’s and dementia.
“It’s also very sad because you’re doing this walk in remembrance of people. It’s going to be difficult for me to walk this year after losing her last year. It is bittersweet, but I think it is so important to collect money and to do this walk and bring attention to Alzheimer’s and dementia.”