Media Coverage

FDA panel reviews Eli Lilly Alzheimer’s drug ahead of agency decision

Outside advisers to the U.S. Food and Drug Administration are meeting on Monday to assess whether Eli Lilly’s (LLY.N), opens new tab experimental Alzheimer’s drug donanemab is safe and effective, ahead of the agency’s decision on approving the drug. The FDA had been expected to rule on the drug earlier this year but then called for an independent advisory panel to weigh in. The regulator is not obligated to follow the recommendations of its outside advisers, but typically does so. “From the beginning, safety has been a concern with these new anti-amyloid monoclonal antibodies,” said Joshua Cahan, from Northwestern’s Feinberg School of Medicine. With its approval of Leqembi, the FDA issued its strongest “boxed” warning about the risk of potentially dangerous brain swelling and bleeding for the entire class of amyloid-lowering drugs.

Added Health Benefits of Wegovy, Zepbound Could Attract More Men, Doctors Say

Evidence that weight-loss drugs like Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound can cut heart disease risk, treat sleep apnea and address other health issues may help convince more men to use them. Men prefer to shed extra pounds with diet and exercise changes before reaching for drugs, if they address their weight at all, doctors and three healthcare industry analysts said in interviews. Women are far less hesitant to seek a physician’s help with weight loss and management, they said. The “typical weight management program is female predominant in our clinic. It’s almost two out of three patients are women, and that’s pretty much common across the country,” said Robert Kushner, MD, obesity medicine researcher at Northwestern’s Feinberg School of Medicine. Kushner said in his practice male patients were showing more interest in these medications, both of which are taken as weekly injections, in light of data showing their wider health benefits. Other physicians suggested that some men may be more open to weight-loss drugs based on recommendations from women in their lives taking the medicines.

Alzheimer’s drug that can slow disease gets backing from FDA advisers

A closely watched Alzheimer’s drug from Eli Lilly won the backing of federal health advisers on Monday, setting the stage for the treatment’s expected approval for people with mild dementia caused by the brain-robbing disease. Food and Drug Administration advisers voted unanimously that the drug’s ability to slow the disease outweighs its risks, including side effects like brain swelling and bleeding that will have to be monitored. In another key difference, Lilly studied taking patients off its drug when they reached very low levels of amyloid, a sticky brain plaque that’s a contributor to Alzheimer’s. Lilly scientists suggested stopping treatment is a key advantage for its drug, which could reduce side effects and costs. But FDA staff said Lilly provided little data supporting the optimal time to stop or how quickly patients might need to restart treatment. Despite those questions, many panelists thought the possibility of stopping doses held promise. “It’s a huge cost savings for the society, we’re talking about expensive treatment, expensive surveillance,” said Tanya Simuni, MD of Northwestern University. She and other experts said patients would need to be tracked and tested to see how they fare and whether they need to resume treatment.

Ultrasound Device Delivers Meds to Better Fight Brain Tumors

One of the biggest obstacles to treating brain cancer is getting tumor-killing drugs past the blood-brain barrier that normally protects the brain from foreign invaders. Now, new research shows that ultrasound waves emitted from a device implanted in a cancer patient’s skull could be the key to getting chemotherapy and immunotherapy drugs into the brain. This ultrasound technology allowed doctors at Northwestern Medicine in Chicago to get a small dose of these drugs past the blood-brain barrier, according to a report published June 6 in the journal Nature Communications. What’s more, the treatment boosted the immune system’s recognition of brain cancer cells, the researchers added. “This is the first report in humans where an ultrasound device has been used to deliver drugs and antibodies to glioblastoma to change the immune system, so it can recognize and attack the brain cancer,” said researcher

You Don’t Need to Obsess Over Frequent Blood Tests to Get Healthier and Live Longer

“Routine bloodwork is not a thing,” says Jeffrey A. Linder, MD, MPH, Professor and Chief of the Division of General Internal Medicine at Northwestern University Feinberg School of Medicine. “There is no medical specialty society that says you should get checked for all of the blood tests on any basis whatsoever.” “This is like when everybody was talking about full-body MRI scans,” Dr. Linder says, referring to last year’s spike in interest around elective full-body imaging after Kim Kardashian posted about Prenuvo. “Now all of a sudden everybody’s talking about blood tests.” Dr. Linder says (and all of the doctors we asked agreed) that once a year is plenty, unless there is cause to investigate a specific symptom or concern. On the other hand, if giving blood doesn’t sound like your idea of fun, feel free to opt out. “I just feel like people are wasting a lot of their time and a lot of their mental energy for not very much of anything,” says Dr. Linder.

Being a Dad May Take Toll on Men’s Hearts

The old joke holds that fatherhood causes a man’s hair to go prematurely gray. Whether or not that’s true, being a father does appear to put men at greater risk of poor heart health later in life, a new study finds. “The changes in heart health we found suggest that the added responsibility of childcare and the stress of transitioning to fatherhood may make it difficult for men to maintain a healthy lifestyle, such as a healthy diet and exercise,” said researcher John James Parker, MD, an assistant professor of pediatrics and general internal medicine at Northwestern University Feinberg School of Medicine in Chicago. Although fathers had worse heart health, the study also found they actually have lower death rates than men without kids. That might be because fathers have a better social support system, and social connectedness has been linked to a lower risk of death, Parker said. “Fathers may also be more likely to have someone as their future caretaker [i.e., their children] to help them attend medical appointments and manage medications and treatments as they get older,” Parker noted in a Northwestern news release. “We also found that fathers had lower rates of depressive symptoms than non-fathers, so mental health may be contributing to the lower age-adjusted death rates in fathers,” Parker added.