Health Care — Second Alzheimer’s treatment gets FDA nod
Today is Friday, and a 13th vote for House Speaker again failed to elect anyone to the position. Maybe 14 is the lucky number.
In health news, the FDA approved a new drug for early stage Alzheimer’s disease, but it may not see widespread uptake unless Medicare changes its coverage rules.
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New Alzheimer’s drug given green light
An experimental Alzheimer’s drug that moderately slows cognitive decline was approved by the Food and Drug Administration (FDA) on Friday.
The drug, called lecanemab, was granted conditional approval based on a study finding it reduced levels of a protein called amyloid from the brains of people with early-stage Alzheimer’s.
The FDA’s decision comes after the agency faced enormous criticism and a congressional investigation for its approval of Aduhelm, a similar type of Alzheimer’s drug.
There were serious concerns about Aduhelm’s efficacy, and even though lecanemab has received a warmer reception from experts, the Aduhelm controversy will likely reverberate.
Lecanemab was approved through the agency’s accelerated pathway, which the FDA can use to approve drugs based on early trial results for serious conditions where there is an unmet medical need, and if the drug is shown to have a reasonable clinical benefit to patients.
“This treatment option is the latest therapy to target and affect the underlying disease process of Alzheimer’s, instead of only treating the symptoms of the disease,” Billy Dunn, director of the FDA’s Office of Neuroscience, said in a statement.
The medication will be sold under the brand name Leqembi and marketed by Japan’s Eisai and its U.S. partner Biogen, which also manufactured Aduhelm.
Cost: Leqembi is given as an infusion twice a month. In a statement, Eisai said the drug will cost an average of $26,500 per year per patient.
Since Alzheimer’s disease primarily impacts seniors who are eligible for Medicare, taxpayers will largely foot the bill for the new drug if it is covered. Roughly 6 million people suffer from the disease in the U.S.
The Centers for Medicare & Medicaid Services (CMS) last spring said it will only cover anti-amyloid drugs that were granted accelerated approval if patients are enrolled in a clinical trial. There are no ongoing trials for Leqembi.
Idaho court upholds laws restricting abortion
The Idaho Supreme Court upheld several state laws restricting abortion access on Thursday, ruling that the state’s constitution does not implicitly grant a right to the procedure.
In a 3-2 decision, the court dismissed the lawsuit brought by Planned Parenthood over three Idaho abortion laws — a near-total abortion ban passed by the state legislature in 2020, a 2021 prohibition on abortions after a fetal heartbeat is detected and a law passed in 2022 that allows potential family members of the fetus to sue for damages.
In Thursday’s decision, the Idaho Supreme Court echoed the U.S. Supreme Court’s reasoning for overturning Roe v. Wade last June, finding that the right to an abortion is not “deeply rooted” in the state’s traditions and history.
“When we apply that test to this dispute, there simply is no support for a conclusion that a right to abortion was ‘deeply rooted’ at the time the Inalienable Rights Clause was adopted,” Justice Robyn Brody wrote in the majority opinion.
However, Brody noted that the state Supreme Court’s ruling does not prevent Idaho voters from “answering the deeply moral and political question of abortion at the polls.”
Rebecca Gibron, CEO of a six-state Planned Parenthood group that covers Kentucky, called the ruling a “dark day for the state of Idaho.”
DEMOCRATIC SEN. BOB CASEY REVEALS CANCER DIAGNOSIS
Third-term Sen. Bob Casey (D-Pa.), who is up for reelection in 2024, announced Thursday that has been diagnosed with prostate cancer, which he said came as “a shock.”
Casey, who was in Washington Tuesday to welcome newly elected Sen. John Fetterman (D-Pa.) to the Capitol, said he expects to undergo surgery soon.
STUDY: 1 IN 4 ADULTS WITH CHRONIC PAIN TURNING TO CANNABIS
More than a quarter of U.S. adults suffering from chronic pain have turned to using cannabis to manage their discomfort, according to a new study published in JAMA Open Network.
Researchers at Michigan Medicine surveyed 1,661 adults last spring with chronic pain who lived in one of the 36 states with active medical cannabis programs and Washington, D.C.
About 26 percent of survey participants reported using cannabis within the past year to manage pain, researchers found.
Most people who used cannabis as a treatment for chronic pain reported substituting cannabis in place of other pain medications, including prescription opioids.
Less than 1 percent said their cannabis use resulted in more opioid, non-opioid or over-the-the-counter pain medication use, according to the study.
“The fact that patients report substituting cannabis for pain medications so much underscores the need for research on the benefits and risk of using cannabis for chronic pain,” said Mark Bicket, assistant professor in the Department of Anesthesiology and co-director of the Michigan Opioid Prescribing Engagement.
FDA: Treatment may be ineffective against variant
The Food and Drug Administration (FDA) said on Friday that AstraZeneca’s preventative monoclonal antibody treatment for COVID-19 is likely ineffective against the XBB.1.5 omicron subvariant due to its similarity to other mutations of the virus that are also not neutralized by the treatment.
In a statement, the FDA said it “does not anticipate that Evusheld will neutralize XBB.1.5.”
“This means that Evusheld may not provide protection against developing COVID-19 for individuals who have received Evusheld and are later exposed to XBB.1.5,” said the agency. “However, we are awaiting additional data to verify that Evusheld is not active against XBB.1.5. We will provide further updates as new information becomes available.”
The treatment was also recommended for use in people who may not be good candidates for coronavirus vaccination or those who have history of developing adverse reactions to COVID-19 shots.
The Centers for Disease Control and Prevention has previously recommended Evusheld to be administered in immunocompromised people who have been vaccinated as a supplement the vaccine’s protection.
Only option for some: Evusheld is currently the only authorized available option for pre-exposure prophylaxis in immunocompromised individuals who may not develop a strong enough immune response from vaccination alone.
WHAT WE’RE READING
More orthopedic physicians sell out to private equity firms, raising alarms about costs and quality (Kaiser Health News)
Officials in Nebraska, South Dakota, Oklahoma begin to probe prisons’ hepatitis C treatment efforts (Stat)
EPA proposes new rule to crack down on deadly air pollution (CNN)
STATE BY STATE
Texas senators cite false COVID vaccine claims in call for new ‘adverse effects’ website (San Antonio Express-News)
Wyoming Medicaid expansion again goes before lawmakers (Casper Star Tribune)
Arkansas medical marijuana sales break annual record (KNWA)
That’s it for today, thanks for reading. Check out The Hill’s Health Care page for the latest news and coverage. See you Monday.
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