Breaking News

Leqembi on the line, taurine in aging, & an avoidable retraction 

June 9, 2023
Reporter, Morning Rounds Writer

Good morning. Two things we'll be watching today:

  • An advisory panel convened by FDA to evaluate a new Alzheimer's drug (see item below on watching with us).
  • Word from an appeals court on an Affordable Care Act provision requiring no-cost coverage of certain preventive services — such as PrEP for HIV, cancer screenings, and mental health screenings. On Wednesday, three judges gave the two parties until today to come up with a possible agreement on staying a federal judge's order blocking the preventive care requirement.

Alzheimer's

FDA advisory panel takes up new Alzheimer's drug

FDA's outside experts are meeting today to consider recommending full approval for Leqembi, the Alzheimer's treatment made by Eisai and Biogen. The drug was granted conditional approval in January based on preliminary evidence showing it could eliminate toxic brain plaques from people diagnosed with early-stage Alzheimer's. Now six independent experts will review a subsequent, larger Phase 3 clinical trial and vote on whether the results confirm Leqembi's benefit.

If the vote is in Leqembi's favor, as FDA documents released Wednesday seem to predict, full approval could follow in July. Today's discussion will center on benefits and risks of the drug in certain patient populations. STAT's Adam Feuerstein and Damian Garde will be writing live updates and analyses here, starting at 10 a.m. ET.


in the lab

You can find taurine in cat food and energy drinks. Now the amino acid is on the aging-research list

What can't taurine do? The amino acid's importance first cropped up 50 years ago in a blind cat, when a nutrition professor figured out taurine deficiency led to retinal degeneration. A new study in Science explores the amino acid in a Noah's Ark of species, concluding that 11 years of supplementing taurine improved bone density, muscle function, body weight, and immune health. "Taurine is hitting the aging brake," said study co-author Vijay Yadav.

Starting with mice before moving on to worms, monkeys, and humans, the scientists observed better blood glucose, less inflammation, lower body-fat percentages, and other cell-level benefits that in the rodents translated into better strength, coordination, and memory. In humans, medical records showed a link between high taurine levels and lower rates of obesity and type 2 diabetes along with better cholesterol and liver health. STAT's Damian Garde has more, including an expert's note of skepticism, next steps, and the Alpo, Garfield, and Red Bull connection.


infectious disease

FDA panel recommends approval of monoclonal antibody to prevent RSV in the youngest kids

First came the RSV vaccine approvals. Now an antibody treatment to protect newborns and young kids from the respiratory virus may be close, too. Yesterday an FDA advisory panel voted twice in favor of the monoclonal antibody Beyfortus, developed by AstraZeneca and to be marketed by Sanofi. The experts unanimously recommended its use in children up to 1 year old; they voted 19 to 2 for use in high-risk children in the second year of life.

RSV can be particularly severe in the very young and the very old. In May, the FDA approved vaccines from GSK and Pfizer for adults over 60. The antibody approach has the advantage of giving a single injection either at birth during RSV season, or in the autumn — less challenging than potentially multiple vaccine doses. Pfizer is seeking approval for a vaccine given during pregnancy to protect newborns. STAT's Helen Branswell has more on what comes next.



Closer Look

After reviewers suggested rejecting it, a paper won acclaim and grant money — all before retraction

RETRACTION_ILLOAdobe, Alex Hogan/STAT

It was a bold claim on a life-and-death subject. A 2017 paper published in Nature Human Behaviour claimed a combination of brain scans and machine learning algorithms could identify people at risk for suicide with 91% accuracy. Based on the work, two of its authors a won a five-year, $3.8 million grant from the NIH to study the method further. But the paper has been retracted, six years after the initial peer reviewers raised questions about the manuscript and suggested rejecting it.

The authors admitted the work was flawed and retracted their article in April, but not before it had been cited 134 times in the scientific literature and ranked in the top 5% of research tracked by Altmetric. All this could have been avoided if the journal had followed the advice of its own reviewers, according to records of the peer review process obtained by Retraction Watch, Ellie Kincaid writes. Read more.


coronavirus

Study finds a link between taking a diabetes drug early in infection and lower risk of long Covid later

Long Covid is a baffling condition with no solution. A new study offers some preliminary hope: People who took the diabetes drug metformin within three days of testing positive for the virus were 41.3% less likely to develop long Covid than those who didn't get the drug. Researchers believe theirs is the first randomized trial to show a treatment that works when given at the time of acute infection, they write in The Lancet: Infectious Diseases.

The absolute risk difference shows 6.3% of people (35 of 564) who took metformin developed long Covid versus 10.4% who didn't (58 of 562) take the drug. There are caveats: The 1,126 trial participants all had overweight or obesity. "An alternative explanation … may be that [metformin] is addressing a tendency to hyperglycemia, which is considered a risk factor for adverse outcomes following infection with Covid," Stephen Lawrence of the University of Warwick, who was not involved in the study, said in a statement.


global health

Newborns are dying of sepsis after antibiotic resistance, especially in lower-income countries

Antibiotic resistance is a worldwide problem whose toll in newborn babies is drawing alarm. A study in PLOS Medicine tracking sepsis in 19 hospitals in 11 countries found that many newborns are dying because antibiotics to treat the bloodstream infection are losing their effectiveness. Almost 1 in 5 infants died of sepsis during the study, conducted from 2018 to 2020. Most of the deaths occurred in low- and middle-income countries, where sepsis has become resistant to antibiotics. The mortality rate among countries ranged from 1.6% to 27.3%, with much higher rates where incomes are lower.

Another worrying statistic: Hospitals in the study collectively used more than 200 different antibiotic combinations, frequently switching when treatments met high resistance. Antibiotics classified by the WHO as "last-line" were often used, despite being recommended only for specific, limited indications to preserve their power. But they were often the only antibiotics available, the authors note. 


More around STAT
Check out more exclusive coverage with a STAT+ subscription
Read premium in-depth biotech, pharma, policy, and life science coverage and analysis with all of our STAT+ articles.

What we're reading

  • China's scientist scorned for baby gene editing is out of jail and back in the lab, NPR
  • Your cholesterol test might not be FDA approved. The agency wants to change that, Wall Street Journal
  • If AI invents a new medicine, who gets the patent? STAT
  • Marburg viral outbreak in Equatorial Guinea ends, says WHO, Reuters
  • Top Senate Republican signals interest in site-neutral reform for hospitals, STAT

Thanks for reading! More Monday,


Enjoying Morning Rounds? Tell us about your experience
Continue reading the latest health & science news with the STAT app
Download on the App Store or get it on Google Play
STAT
STAT, 1 Exchange Place, Boston, MA
©2023, All Rights Reserved.

No comments