FDA DECIDES FATE OF NEW ALZHEIMER’S DRUG — Today marks the FDA’s target deadline to decide whether to approve Eisai’s and Biogen’s lecanemab, an antibody therapy that targets the amyloid proteins thought to cause Alzheimer’s disease, Katherine reports. Should the drug receive a green light from the agency, it would be the second new Alzheimer’s therapy to come to market in two years after the field was stuck with a dearth of treatments for the past two decades. Late last year, the companies published the results of a 1,500-person Phase III trial showing that lecanemab modestly slowed the progression of participants’ cognitive decline and successfully cleared amyloid from their brains. That data is enough to convince some patients of the drug’s merit. “I wanted it [lecanemab] five minutes ago,” Tony Gonzales, a 47-year-old living with early Alzheimer’s disease in California and member of the Alzheimer’s Association’s early-stage advisory committee, told Katherine. But health experts are divided as to whether those effects will meaningfully benefit patients — and some have concerns about the drug’s safety profile. In the trial, 14 percent of patients who received the drug endured side effects that included brain swelling and bleeding, compared to roughly 11 percent in the placebo group. Three participants who had opted to take lecanemab died after the randomized portion of the Phase III trial concluded, although it’s not clear whether the drug contributed to their deaths. Earlier this week, clinicians from Northwestern University published a letter regarding one of those deaths, which occurred shortly after a patient had a stroke after receiving a third infusion of the drug. They noted that it would be “unusual” for a patient who recently received lecanemab to have such severe complications from stroke treatment alone. It’s also unclear whether Medicare will cover lecanemab: Most people eligible for lecanemab will be Medicare beneficiaries. The Centers for Medicare and Medicaid Services determined last year that if drugs like lecanemab received accelerated approval from the FDA, it would only cover them for patients enrolled in a randomized clinical trial. Eisai and Biogen asked the FDA to approve lecanemab under the accelerated pathway. Since they submitted that application, they have wrapped up their Phase III trial — and no future randomized trials are planned — meaning patients could be on the hook for tens of thousands of dollars annually for the treatment, according to previous estimates from Eisai. IT’S FRIDAY. WELCOME TO PRESCRIPTION PULSE. Internet searches for gym memberships are at an all-time high in the U.S., but your authors are fans of good old-fashioned walks (or runs!) outside. Send tips, feedback and outdoor activity recommendations to David Lim (dlim@politico.com or @davidalim), Lauren Gardner (lgardner@politico.com or @Gardner_LM) or Katherine Ellen Foley (kfoley@politico.com or @katherineefoley). TODAY ON OUR PULSE CHECK PODCAST, Lauren talks with Daniel Payne about the results of a survey from the Substance Abuse and Mental Health Services Administration, which shows that 1 in 3 Americans had a substance abuse disorder or mental illness in 2021. Plus, Ben Leonard talks with Amy Abernethy, president of Verily’s clinical research business and the former No. 2 at the FDA, about barriers to improving trials, the new Advanced Research Projects Agency for Health and more.
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