Decision day for lecanemab

Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy.

Jan 06, 2023 View in browser   By Katherine Ellen Foley and Lauren Gardner Driving the Day The FDA is due to decide whether to approve Biogen's and Eisai's new Alzheimer's drug. | Steven Senne/AP Photo 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. Listen to today's Pulse Check podcast Eye on the FDA FDA DENIES ABORTION PILL PETITIONS FROM RIGHT, LEFT — Earlier this week, the FDA denied two citizen petitions related to the abortion pill mifepristone, declining to loosen or tighten the rules around who can obtain the drugs, as well as when and how, POLITICO's Alice Miranda Ollstein scoops. The agency rejected a demand from the anti-abortion group Students for Life to forbid most prescriptions via telemedicine and to revert to the 2011 restrictions on mifepristone that the FDA has since relaxed. The group also petitioned to have the drug's use limited to the first seven weeks of pregnancy instead of the current 10, among other asks. The FDA also denied an American College of Obstetricians and Gynecologists petition to make the pills easier to obtain for patients using them to treat a miscarriage and not an elective abortion. Patrizia Cavazzoni, the director of the Center for Drug Evaluation and Research, wrote that mifepristone's manufacturers would have to seek a label change and submit data supporting the addition of miscarriage management. Reaction: Kristi Hamrick, the policy director of Students for Life, predicted her group and others would take legal action against the FDA. Rachel Tetlow, the director of ACOG Federal Affairs, warned that people experiencing miscarriages will encounter "politically motivated abortion restrictions that have no basis in science." CVS and Walgreens seek certification that will allow their pharmacies to dispense the abortion pill mifepristone. | Scott Olson/Getty Images | Getty MAJOR PHARMACIES PLAN TO DISPENSE MIFEPRISTONE — Spokespeople for CVS and Walgreens confirmed Thursday that the pharmacies plan to become certified to dispense mifepristone under the FDA's updated safety program requirements for the drug. CVS plans to seek certification "where legally permissible," spokesperson Amy Thibault said. Meanwhile, Walgreens is "working through the registration, necessary training of our pharmacists, as well as evaluating our pharmacy network in terms of where we normally dispense products that have extra FDA requirements and will dispense these consistent with federal and state laws," spokesperson Marty Maloney said. To be certified to dispense mifepristone, pharmacies must authorize a representative to carry out the certification process and manage implementation and compliance with the FDA's Risk Evaluation and Mitigation Strategy program. Pharmacy locations must be able to ship the pills in a way that's trackable and provide the drug to patients within four days of prescription receipt — and, if they can't, confirm with the prescriber the appropriateness of dispensing mifepristone beyond that timeframe. FDA EXPECTED TO PUBLISH 38 RULES IN 2023 — This week, the Office of Information and Regulatory Affairs released the Fall 2022 Unified Agenda containing rules that agencies government-wide hope to finalize this spring. The FDA is not obligated to stick to the timeline it outlines in the agenda, but these are the rules we're paying the closest attention to: — A proposed rule that could loosen blood donation restrictions for gay and bisexual men — A proposed rule that would update the Biologic License Applications process to encourage more product competition — A final rule that would ban menthol cigarettes and another that would ban flavored cigars — A proposed rule that would limit the amount of nicotine in tobacco products Pharma Moves Ty Bofferding was named communications director for the HELP Committee minority office. Peter Fise has joined Tarplin, Downs & Young. He was most recently health counsel to Senate Finance Chair Ron Wyden(D-Ore.). Jon Heppen has joined Sen. Angus King's (I-Maine) office as a legislative assistant overseeing health policy. He previously worked for Rep. Cheri Bustos (D-Ill.), who didn't run for reelection in 2022. Priya Singhal has been promoted to executive vice president and head of development at Biogen. Previously, she was the company's head of global safety and regulatory sciences and interim head of research and development. Singhal will also serve as the interim executive vice president and head of research until the company hires a new leader for the role. Quick Hits Many baby foods are riddled with heavy metals, a Bloomberg investigation by Gary Harki, Celine Castronuovo, Julie Steinberg, Kaustuv Basu and Alex Ruoff finds. The Idaho Supreme Court upholds a near-total ban on abortion, while the South Carolina Supreme Court rules that abortion is protected under its state constitution, POLITICO's Megan Messerly writes. For STAT, Isabella Cueto and Lacey Lyons detail the barriers people with disabilities face when seeking reproductive care. Document Drawer The FDA has dismissed and denied two petitions from PhRMA asking the agency to generally refrain from authorizing the reimportation of insulin or granting waivers to authorize the personal importation of drugs.   Follow us on Twitter David Lim @davidalim Lauren Gardner @Gardner_LM Katherine Ellen Foley @katherineefoley   Follow us

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