AIMING BEYOND AMYLOID — The FDA is expected to grant full approval to Leqembi, an Alzheimer’s drug from Eisai and Biogen. But drugmakers are already eyeing the field’s future. For decades, the therapeutic pipeline has been dominated by large pharmaceutical companies focused on addressing the misshapen proteins called amyloid, which some scientists believe is one cause of the disease. But now, the first two treatments to address amyloid, Leqembi and Aduhelm, appear to only modestly slow the disease with risks of severe side effects. And with Medicare’s unwavering decision to limit coverage, most of the estimated 100,000 patients eligible to take the drugs have been unable to get them. Even with traditional approval, Eisai estimates that only 10,000 patients will receive the drug by April 2024. But as new research about the disease has unfolded, drugmakers large and small are turning their focus to other targets, Katherine reports. The treatments won’t make it to the market for a few years, but clinicians hope the drugs will eventually make up a robust treatment landscape. Some of those treatments go after tau, a protein also thought to contribute to cognitive decline. Tangles of tau often develop after patients develop clumps of amyloid, but they persist even after amyloid is removed. Some of these treatments in mid-stage trials aim to remove tau tangles, while others try to prevent the brain from producing the protein. Other drug companies are focusing on the brain’s immune system. Some newer drugmakers, like the startup NeuroTherapia, think cognitive decline is related to inflammation. Other drugmakers, like the startup Alector, believe the immune system could be trained to more efficiently go after amyloid and tau. And some researchers think existing treatments for other diseases could be repurposed. Scott Turner, director of the Memory Disorders Program at Georgetown University, told Katherine that he and his team are conducting clinical trials to see whether nicotine patches can help with some cognitive symptoms of Alzheimer’s. Clinicians aren’t giving up on amyloid just yet, though. “It’s setting things in the right direction, but it’s not going to bring us all the way home,” Ronald Petersen, director of the Mayo Clinic’s Alzheimer's Disease Research Center, told Katherine. Large drug companies, including Eli Lilly, Roche and Genentech, have anti-amyloid therapies in mid- to late-stage development. Lilly plans to ask the FDA to grant traditional approval for its anti-amyloid treatment, donanemab, later this year. IT'S TUESDAY. WELCOME TO PRESCRIPTION PULSE. The House and the Senate may be out until July 7, but we know there’s never a dull moment in this field. Send news and tips to David Lim (dlim@politico.com or @davidalim) or Katherine Ellen Foley (kfoley@politico.com or @katherineefoley). TODAY ON OUR PULSE CHECK PODCAST, your host Ben Leonard talks with Erin Schumaker, who provides insight into the future of psychedelic drug research and development now that the FDA has issued its first draft guidance for designing clinical trials using the drugs.
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