| | | | |  | | By David Lim and Lauren Gardner | | Presented by |  | | | | | | | 
Eli Lilly's drug to treat Alzheimer's disease garnered an FDA advisory committee's recommendation for agency approval. | Darron Cummings/AP | ANOTHER ALZHEIMER’S DRUG: An FDA advisory committee unanimously recommended Monday that the agency approve a new Alzheimer’s treatment despite some unanswered questions about its use in certain patients. The daylong meeting was a pendulum swing from those that preceded the agency’s 2021 accelerated approval of Aduhelm, the Alzheimer’s drug that Biogen pulled from the market in January amid low uptake and a battered reputation. The FDA’s endorsement came despite conflicting clinical trial data and a “no” recommendation from its neurological drug advisers, and the decision prompted several members to resign from the panel. Not apples and oranges: Eli Lilly’s donanemab is another anti-amyloid monoclonal antibody like Aduhelm, which targets a protein theorized to contribute to the disease. But its clinical trial results showed that it successfully cleared most amyloid plaque in the brains of 60 percent of participants in the drug treatment arm while also slowing cognitive decline — a datapoint the company said offers some patients the chance to stop taking the infusion if they hit a certain benchmark. Still, industry critics argued during the meeting’s public comment portion that the drug’s effectiveness was minimal compared to its risks, which include potentially fatal brain bleeds. “Like its predecessors … it does not improve how a patient feels, functions or survives, and the net effect of these drugs appears to be harm,” Judy Butler, senior research fellow at Georgetown University’s PharmedOut project, said of donanemab and earlier anti-amyloid treatments. But: The agency and its advisers agreed it’s unclear what the best treatment regimen is for patients who clear amyloid below a certain threshold. They also bemoaned a lack of diversity in Lilly’s trials, which were dominated by white participants. But all committee members said they believed the drug’s benefits outweigh its risks, especially for a disease with no cure. Building blocks: Alzheimer’s advocates say the approval of additional treatment options will help lay the groundwork for more drug innovation, including the possibility of combination therapies that could be used to more precisely treat individuals’ unique manifestations of the disease. “We must continue fostering innovation and progress to move closer to the day where Alzheimer’s is treated on an individual basis with the help of precision medicine, ultimately halting the progression or preventing the onset of the disease altogether,” Dr. Howard Fillit, co-founder and chief science officer of the Alzheimer’s Drug Discovery Foundation, said in a statement. IT’S TUESDAY. WELCOME BACK TO PRESCRIPTION PULSE. We are big fans of the “what D.C. statue would win in a fight” debate. Send news and tips to David Lim (dlim@politico.com or @davidalim) and Lauren Gardner (lgardner@politico.com or @Gardner_LM).
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Abortion pill language has been omitted from a House spending bill that covers the FDA. | Charlie Riedel/AP | MONEY MATTERS — The House Appropriations subcommittee in charge of FDA funding is slated to mark up its fiscal 2025 bill this evening — and a controversial abortion pill rider from last year is not in the original text. The decision not to relitigate the policy that would have effectively banned the mail delivery of mifepristone is a sign that GOP leaders want to sidestep an internal fight over the issue, POLITICO’s Jennifer Scholtes reports. But the text, released late Monday, still contains several policies that will draw opposition from Democrats — and it is unclear whether the bill will cross the finish line before the November election.
| | | | THE GOLD STANDARD OF HEALTHCARE POLICY REPORTING & INTELLIGENCE: POLITICO has more than 500 journalists delivering unrivaled reporting and illuminating the policy and regulatory landscape for those who need to know what’s next. Throughout the election and the legislative and regulatory pushes that will follow, POLITICO Pro is indispensable to those who need to make informed decisions fast. The Pro platform dives deeper into critical and quickly evolving sectors and industries, like healthcare, equipping policymakers and those who shape legislation and regulation with essential news and intelligence from the world’s best politics and policy journalists.
Our newsroom is deeper, more experienced and better sourced than any other. Our healthcare reporting team—including Alice Miranda Ollstein, Megan Messerly and Robert King—is embedded with the market-moving legislative committees and agencies in Washington and across states, delivering unparalleled coverage of health policy and the healthcare industry. We bring subscribers inside the conversations that determine policy outcomes and the future of industries, providing insight that cannot be found anywhere else. Get the premier news and policy intelligence service, SUBSCRIBE TO POLITICO PRO TODAY. | | | | | | | | FDA, DOJ LAUNCH E-CIG TASK FORCE — The FDA and the Justice Department are teaming up to crack down on the sale and production of illegal e-cigarettes by seeking civil or criminal penalties against those selling or distributing such products, POLITICO’s Chelsea Cirruzzo reports. The new multi-agency task force, unveiled by the Biden administration Monday, also includes the Bureau of Alcohol, Tobacco, Firearms and Explosives, the U.S. Marshals Service, the U.S. Postal Inspection Service and the Federal Trade Commission. “The establishment of this Task Force makes clear that vigorous enforcement of the tobacco laws is a government-wide priority,” Acting Associate Attorney General Benjamin Mizer said in a statement. The announcement came days ahead of a Senate Judiciary Committee hearing slated for Wednesday on boosting enforcement against illegal e-cigarettes. “New partnerships only matter if our federal agencies use their enforcement tools instead of cowering to the tobacco industry’s lawyers,” Rep. Dick Durbin (D-Ill.), chair of the Senate Judiciary Committee, said in a statement. “Thus far, our agencies have failed to prevent a wave of youth e-cigarette addiction.”
| | | | A message from Evernorth Health Services:   | | | | | FDA: PREP FOR HURRICANES — The FDA’s medical device center reupped its hurricane advice to manufacturers Monday — noting that the severe weather season began this month. “It is important to act now, as shortages of medical devices could directly impact patients’ lives, particularly our most vulnerable populations, and jeopardize our national security,” the FDA said in an email. The agency said manufacturers should consider shipping finished products from facilities that might be impacted by a forecasted hurricane and identify sterilization facilities that could be affected by severe weather. It also suggested that businesses forecast demand to understand if there is enough capacity if a storm impacts operations. FDA LAUNCHES DRUG SAFETY PROGRAM — A new FDA drug center effort to understand how emerging artificial intelligence tools can be used to conduct pharmacovigilance — the monitoring, detection, assessment and prevention of drug adverse events — was announced Monday. The Emerging Drug Safety Technology Program, published in the Federal Register, will have drug regulators meeting with academia, contract research organizations, vendors and software developers to discuss the use of AI. “FDA expects increased communication with industry and/or other relevant parties during [EDST meetings] will accelerate our understanding of how AI-enabled tools are being used for PV, their associated risks and benefits and barriers to implementation,” the agency said in an email.
| | | | JOIN US ON 6/13 FOR A TALK ON THE FUTURE OF HEALTH CARE: As Congress and the White House work to strengthen health care affordability and access, innovative technologies and treatments are increasingly important for patient health and lower costs. What barriers are appearing as new tech emerges? Is the Medicare payment process keeping up with new technologies and procedures? Join us on June 13 as POLITICO convenes a panel of lawmakers, officials and experts to discuss what policy solutions could expand access to innovative therapies and tech. REGISTER HERE. | | | | | | | | | MODERNA: COMBO FLU-COVID SHOT SHOWS PROMISE — A dual shot for flu and Covid-19 had a higher immune response than vaccines on the market used in a Phase III trial, Moderna said Monday. The ongoing trial is evaluating the mRNA vaccine in two groups of approximately 4,000 adults. “mRNA-1083 showed an acceptable tolerability and safety profile,” the company said in a press release. “The majority of solicited adverse reactions were grade 1 or 2 in severity and consistent with the licensed vaccines used in the trial. The most commonly solicited adverse reactions were injection site pain, fatigue, myalgia and headache.” The company said it plans to present clinical data at an upcoming conference, submit it to a journal for publication and meet with regulators about “next steps.”
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