Healthcare – A second treatment for Alzheimer’s disease gets FDA approval

Today is Friday, the thirteenth vote for Speaker again Failed to elect anyone to the position. Maybe 14 is your lucky number.

In health news, the U.S. Food and Drug Administration has approved a new drug for early-stage Alzheimer’s disease, but it may not get widespread absorption unless Medicare changes its coverage rules.

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Giving a new Alzheimer’s drug the green light

An experimental Alzheimer’s disease drug that moderately slows cognitive decline was approved by the Food and Drug Administration (FDA) on Friday.

The drug, called lecanemab, won conditional approval based on a study that found it reduced levels of a protein called amyloid in the brains of people with early-stage Alzheimer’s disease.

  • The FDA’s decision comes after the agency faced massive criticism and a congressional investigation for its approval of Aduhelm, a similar type of Alzheimer’s drug.
  • There have been serious concerns about Aduhelm’s effectiveness, and although lecanemab has received a much warmer reception from experts, the Aduhelm controversy is likely to reverberate.

Lecanemab has been approved through the agency’s Fast Track, which the FDA can use to approve drugs based on the results of early trials for serious conditions where there is an unmet medical need, and if the drug is shown to have reasonable clinical benefit for patients.

“This treatment option is the latest treatment to target and influence the underlying disease process of Alzheimer’s disease, rather than just treating the symptoms of the disease,” Billy Dunn, director of the FDA’s Office of Neuroscience, said in a statement.

The drug will be sold under the brand name Leqembi and marketed by Japan’s Eisai and its US partner Biogen, which also made Aduhelm.

cost: Leqembi is injected twice a month. The drug will cost an average of $26,500 per year, per patient, Esay said in a statement.

  • Since Alzheimer’s primarily affects older adults who qualify for Medicare, taxpayers will largely foot the bill for the new drug if it is covered. Approximately 6 million people suffer from this disease in the United States
  • The Centers for Medicare and Medicaid Services (CMS) said last spring that it will only cover anti-amyloid drugs that have been granted fast-track approval if patients are enrolled in a clinical trial. There are no ongoing trials for Leqembi.

Read more here.

Idaho court upholds laws restricting abortion

The Idaho Supreme Court upheld several state laws that restrict access to abortion Thursday, ruling that the state constitution does not implicitly grant the right to the procedure.

In a 3-2 decision, the court dismissed Planned Parenthood’s lawsuit over three Idaho abortion laws — the near-total abortion ban passed by the state legislature in 2020, the 2021 abortion ban after fetal heartbeat detection and the statute of limitations. It was passed in 2022 that allows potential family members of a fetus to sue for damages.

In Thursday’s decision, the Idaho Supreme Court reiterated the U.S. Supreme Court’s reasoning to overturn Roe v. Wade last June, finding that the right to abortion is not “deeply rooted” in the state’s traditions and history.

  • Justice Robin Brody wrote in the majority opinion: “When we apply this test to this dispute, there is simply no support for the conclusion that the right to abortion was ‘deeply entrenched’ at the time the Unalienable Rights Clause was adopted.”
  • However, Brody noted that the state Supreme Court ruling does not prevent Idaho voters from “answering the deep moral and political question of abortion at the polls.”

Rebecca Gibron, executive director of the six-state Planned Parenthood group that covers Kentucky, called the ruling “a dark day for Idaho.”

Read more here.

Sin democracy. Bob Casey reveals his cancer diagnosis

Third-term Sen. Bob Casey (D-Penn), who will run for re-election in 2024, announced Thursday that he had been diagnosed with prostate cancer, which he said came as a “shock.”

Casey, who was in Washington on Tuesday to welcome newly elected Sen. John Fetterman (D-Penn.) to the Capitol, said he expects to undergo surgery soon.

Read more here.

Study: 1 in 4 adults with chronic pain turn to cannabis

More than a quarter of adults in the United States with chronic pain have turned to cannabis use to control 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.

Researchers found that about 26 percent of survey participants reported using cannabis within the past year for pain management.

  • Most people who have used cannabis as a treatment for chronic pain report substituting cannabis for other pain relievers, including prescription opioids.
  • Less than 1 percent said their cannabis use led to more use of opioids, non-opiids, or over-the-counter painkillers, according to the study.

Description of the engagement, said Mark Beckett, assistant professor in the department of anesthesiology and co-director of Michigan Opioid.

Read more here

Food and Drug Administration: Treatment may be ineffective against the variant

The Food and Drug Administration (FDA) said Friday that AstraZeneca’s prophylactic treatment with monoclonal antibodies 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 not also 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 the development of COVID-19 in individuals who received Evusheld and were subsequently exposed to XBB.1.5,” the agency said. “However, we are awaiting additional data to verify that Evusheld is not active against XBB.1.5. We will provide further updates as soon as new information becomes available.”

  • The treatment has also been recommended for people who may not be good candidates for coronavirus vaccination or those with a history of developing adverse reactions to COVID-19 shots.
  • The Centers for Disease Control and Prevention previously recommended EvoShield for immunocompromised people who have been vaccinated as a supplement to vaccine prophylaxis.

The only option for some: Evusheld is currently the only authorized option available for pre-exposure prophylaxis for immunocompromised people who may not develop an immune response strong enough from vaccination alone.

Read more here.

what we read

  • More orthopedists are selling to private equity firms, sounding the alarm about costs and quality (Kaiser Health News)
  • Officials in Nebraska, South Dakota and Oklahoma have begun investigating efforts to treat hepatitis C in prisons (stat)
  • EPA proposes new rule to crack down on deadly air pollution (CNN)

State by state

  • Texas Senators cite false claims about COVID vaccine in advocacy for new ‘adverse effects’ website (San Antonio Express News)
  • Wyoming’s Medicaid expansion again goes before lawmakers (Casper Star Tribune)
  • Medical marijuana sales in Arkansas break annual recordsKNWA)

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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