Former Food and Drug Administration Associate Commissioner Peter Pitts told Newsmax that the drug lecanemab's progress is "good news" for Alzheimer's patients and their families.
The FDA could decide this week whether to grant accelerated approval to the experimental Alzheimer’s drug. Lecanemab is one of the first experimental dementia drugs to appear to slow the progression of cognitive decline, according to results from a study earlier this year.
The drug raised some safety concerns due to its association with specific serious adverse effects in trial patients, including brain swelling and bleeding.
"It’s being reviewed through a process called accelerated approval, which is for drugs that treat serious and life-threatening diseases where there really aren’t significant treatments," Pitts, president of the Center for Medicine in the Public Interest, said on "National Report."
The FDA is expected to make a decision regarding lecanemab on Thursday.
"The study shows that 14% of people in the clinical trials who were given [the] drug had serious side effects," Pitt said. "But 11.3% [of] people that didn’t get the drug who were on the placebo-arm also did, so there is only 2.7% shift."
He said patients and their caregivers "really need to have the power to make their own decisions."
When asked how substantial these findings were, Pitts responded, "It's pretty significant; anything that slows the continued progression of Alzheimer's disease is very important.
"Obviously for patients, and this is going to be indicated for patients with mild Alzheimer's disease, so the earlier stages of Alzheimer’s disease.
"Clearly, there are therapeutic benefits for patients and their loved ones, but it is also important that when people move from mild to moderate Alzheimer's disease — which is the next stage — their costs as patients triple, so there are significant savings that can be recognized by our healthcare system."
About 6 million Americans have Alzheimer’s disease, and "that number is growing," Pitt said.
"Being able to slow it down is a good first step," he said.
"Scientists are willing to invest in ... the research and development for this disease, and I think should the FDA approve this drug and should insurance companies ordain to reimburse forward, it sends a positive signal that more research needs to be funded."
He said the drug might be available at six months or longer, depending on manufacturing; also, he's unsure whether or how Medicaid, Medicare or private insurance would pay for it.
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