Health
FDA approves first medication for obstructive sleep apnea, which also promotes weight loss
The first medication for obstructive sleep apnea has been approved by the U.S. Food and Drug Administration (FDA).
On Dec. 20, the FDA announced that the agency has approved Eli Lilly’s Zepbound (tirzepatide) to treat moderate to severe obstructive sleep apnea (OSA) in adults with obesity.
The drug is to be paired with a reduced-calorie diet and increased physical activity, the FDA noted.
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Sally Seymour, M.D., director of the Division of Pulmonology, Allergy and Critical Care in the FDA’s Center for Drug Evaluation and Research in Washington, D.C., applauded the approval in an announcement.
Happy and healthy senior man sleeping deeply on his left side without snoring (iStock)
“Today’s approval marks the first drug treatment option for certain patients with obstructive sleep apnea,” Seymour wrote. “This is a major step forward for patients with obstructive sleep apnea.”
OSA occurs when the upper airway becomes blocked and causes pauses in breathing during sleep, according to the FDA. The condition is more common in people who are overweight or obese.
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Similar to semaglutide treatments like Ozempic and Wegovy, Zepbound activates receptors of hormones secreted from the intestine (GLP-1 and GIP) to reduce appetite and food intake.
About 30 million people suffer from sleep apnea in the U.S.
Studies show that by reducing body weight, Zepbound “also improves OSA,” the FDA noted.
In a 52-week study, participants treated with Zepbound experienced “statistically significant and clinically meaningful reduction in events of apnea or hypopnea,” and a large share of participants achieved remission or “resolution of symptoms.”
Zepbound improves obstructive sleep apnea by reducing body weight, studies show. (iStock)
Zepbound-treated patients also reported a significant decrease in body weight, the FDA mentioned.
The drug can reportedly cause side effects like nausea, diarrhea, vomiting, constipation, stomach discomfort and pain, injection site reactions, fatigue, allergic reactions (typically fever and rash), burping, hair loss and gastroesophageal reflux disease.
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While Zepbound causes thyroid C-cell tumors in rats, it’s unknown whether it causes these tumors in humans, so it should not be used by patients with a personal or family history of medullary thyroid cancer or with multiple endocrine neoplasia syndrome type 2, per the FDA.
The agency encourages all OSA patients to consult with a doctor before taking Zepbound and to monitor for any complications.
One sleep expert called the FDA’s approval a “promising advancement for the millions of people who suffer from this condition.” (iStock)
Sleep expert Dr. Wendy Troxel, who is a RAND Corporation senior behavioral specialist and licensed clinical psychologist in Utah, called the FDA’s approval a “promising advancement for the millions of people who suffer from this condition.”
“Zepbound promotes weight loss and has been shown to reduce apnea events.”
About 30 million people suffer from sleep apnea in the U.S., Troxel told Fox News Digital.
While the most common treatment for sleep apnea — positive airway pressure (PAP) — is “highly effective” at treating the condition, up to 50% of patients are “non-adherent,” she said.
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“Zepbound promotes weight loss and has been shown to reduce apnea events,” Troxel noted.
“For obese individuals with moderate to severe sleep apnea, this new treatment option may offer an important alternative or adjunctive treatment, particularly for those who struggle with sleep apnea therapies, such as positive airway pressure.”
People with a history of severe allergic reaction to tirzepatide should not use Zepbound, the FDA warned in a news release. (iStock)
Troxel added that treating sleep apnea is “critical not only for the patient’s health and well-being, but also for their bed partners, who are often the ‘hidden casualties’ of untreated sleep apnea, given that loud snoring and gasping for air are primary symptoms,” she said.
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Dr. William Lu, medical director of Dreem Health in San Francisco, told Fox News Digital that obesity and sleep apnea are “two of the most prevalent health conditions that affect Americans today.”
“We still need to emphasize shifting the diet and health habits of many, but this is a fantastic start.”
“And they go hand in hand,” he said. “For the patients who qualify and have no contraindications, tirzepatide has the opportunity to be a generational medication that can help people lose weight, reduce the severity of sleep apnea and improve overall health.”
“We still need to emphasize shifting the diet and health habits of many, but this is a fantastic start.”
Getting tested for sleep apnea is “critical for your health,” Lu said, and could also be a requirement for getting coverage for the medication.
Fox News Digital reached out to Eli Lilly requesting comment.
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A new injectable therapy is showing positive results in reducing melanoma throughout a five-year period.
The personalized mRNA cancer therapy, called intismeran autogene, combined with the cancer immunotherapy drug KEYTRUDA (pembrolizumab), is a collaboration between Merck and Moderna.
The results from the phase 2b KEYNOTE-942 study were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago on May 27.
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After about a five-year follow-up, the combo drug was found to reduce the risk of melanoma recurrence or death by 49% compared to pembrolizumab alone.
The researchers analyzed data from 157 patients with high-risk stage 3 and 4 melanoma whose cancer had been removed via surgery. The participants were split into two groups — one received the combo therapy and the other only received pembrolizumab, according to a press release.
The therapy was found to reduce the risk of melanoma recurrence or death by 49% compared to pembrolizumab alone after a five-year follow-up. (iStock)
The findings revealed that the combination group saw benefits that were “sustained and durable over time.”
Intismeran autogene is designed using mutations identified in a patient’s own tumor, with the intention of teaching the immune system what the cancer looks like so that it can recognize and attack it.
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According to the researchers, intismeran is “well-tolerated” with a “manageable” safety profile.
The most commonly cited side effects of the personalized mRNA vaccine plus KEYTRUDA were fatigue, injection-site pain, chills, fever and headache. The researchers reported no new long-term safety concerns and no severe vaccine-related adverse events.
The combination therapy is currently being evaluated in a phase 3 study — the final confirmation stage.
Patients with late-stage melanoma have a “significant risk” of cancer recurrence, according to an expert. (iStock)
In a Merck press release from January, Kyle Holen, MD, Moderna’s senior vice president and head of development, oncology and therapeutics, noted that this data highlights the “potential of a prolonged benefit … in patients with resected high-risk melanoma.”
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“We continue to invest in our platform in oncology because of encouraging outcomes like these, which illustrate mRNA’s potential in cancer care,” he said.
Dr. Marjorie Green, senior vice president and head of oncology, global clinical development at Merck Research Laboratories, also commented that for many patients with stage 3 or 4 melanoma, there is a “significant risk of recurrence following surgery.”
Researchers confirmed that the combination therapy is currently being evaluated in a phase 3 study. (iStock)
“As such, demonstrating the longer-term potential of intismeran autogene and KEYTRUDA to reduce the risk of recurrence for certain patients with melanoma is a meaningful milestone,” she said.
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The company cited encouraging five-year follow-up data and pointed to upcoming late-stage INTerpath trial results with Moderna in several hard-to-treat cancers.
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An accidental lab discovery has opened the door to entirely new ways of preventing the flu.
While investigating how influenza replicates, researchers discovered that different flu strains use completely different strategies to infiltrate human cells, SWNS reported.
By targeting the specific molecules the viruses rely on, scientists found that they could block them from entering new cells and halt their replication altogether.
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Researchers say these “fundamental insights” into seasonal influenza highlight a clear path toward developing better preventive medications.
“The hope is that fundamental, curiosity-based research like this helps to pave the way for novel strategies to treat and prevent influenza infections,” principal investigator Dr. Emily Bruce, from the University of Vermont’s Larner College of Medicine, said in the SWNS report.
While investigating how influenza replicates, researchers discovered that different flu strains use completely different strategies to infiltrate human cells. (iStock)
While several flu strains cause illness, H1N1 and H3N2 influenza A viruses are the most common. However, current flu tests cannot differentiate between them, and clinical treatments are identical for both.
Although vaccines and antivirals are available, Bruce noted a “dire” need for better medications to stop the virus from spreading cell to xxcell.
“You don’t get sick when a virus is in one cell,” he noted. “You get sick because a virus replicates itself and goes into many more cells.”
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The study, which was published in The Journal of Virology, originally aimed to map how viral RNA segments are transported within cells to create new viral particles.
The team used H1N1 and H3N2 viruses isolated from the nasal passages of positive patients in 2022.
Clinical treatments remain identical for both primary strains of the flu virus. (iStock)
During the investigation, the team unexpectedly stumbled upon a cellular pathway that blocked the virus from entering lung cells, SWNS reported.
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The data revealed that when a specific human protein called Rab11B was depleted, H3N2 viruses failed to enter human lung cells. H1N1 viruses were completely unaffected.
Using reverse genetics, the team mapped this defect and uncovered a brand-new, H3N2-specific role for Rab11B during viral entry.
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This discovery challenged the scientific assumption that all flu viruses enter cells the same way.
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“Viruses are like pirates from different countries hijacking someone’s ship,” Bruce said. “Different viruses, like different types of pirates, use different methods to get onboard.”
This discovery challenged the scientific assumption that all flu viruses enter cells the same way. (iStock)
“We had previously thought that all flu viruses used the same way to get into a cell, but we discovered that this is not true,” she went on. “H1N1 and H3N2 need different proteins to get in, and if you get rid of the right protein, a specific virus can’t get in.”
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While these findings identify a critical cellular pathway for viral entry, the study was conducted using isolated cells, the researchers acknowledged.
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Further research is needed to determine whether blocking the protein is safe and effective within a live, complex human respiratory system.
Bruce and the team hope to conduct further research to determine whether this Rab11B-dependency is a fundamental property of H3N2, or if it’s a trait unique to currently circulating flu strains.
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Eating processed meat like ham, sausage and bacon may be linked to a higher risk of certain types of cancer, according to new research.
While health organizations have already confirmed that processed meat can contribute to colon cancer, this study looked closer at cancers in the upper digestive tract, where the link has historically been less clear.
To understand these connections, researchers from the European Prospective Investigation into Cancer and Nutrition (EPIC), one of the world’s largest long-term nutrition and cancer cohorts, tracked the health and diets of 450,112 people across Europe for an average of 14 years.
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The study group included 131,426 men and 318,686 women, according to the study’s press release.
During the follow-up period, 876 people developed stomach cancer and 215 people developed esophageal adenocarcinoma, which is cancer of the tube connecting the mouth to the stomach.
For female participants, eating both processed meat and white meat was linked to an increased risk of developing the disease. (iStock)
Researchers tracked where the stomach cancers grew, separating them into the upper part of the stomach near the throat and the lower part of the stomach.
The researchers also sorted the tumors into two categories based on how the cancer cells appeared under a microscope: intestinal, which forms more organized structures, and diffuse, in which the cells are more scattered throughout the tissue.
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After adjusting for other lifestyle factors, the researchers found that for every extra 30 grams of processed meat a person ate per day, their overall risk of stomach cancer went up by 9%. Eating that same extra 30 grams a day was also linked to a 13% higher risk of esophageal adenocarcinoma.
A standard single slice of regular deli-sliced ham or lunch meat averages around 28 grams, according to USDA data and nutritional tracking databases.
An extra 20 grams of white meat, such as chicken and turkey, was linked to a 12% higher risk of cancer in the main body of the stomach. (iStock)
An extra 20 grams of white meat, such as chicken or turkey, was linked to a 12% higher risk of cancer in the main body of the stomach, the researchers noted.
The study also revealed differences between men and women. For male participants, only processed meat showed a clear, statistically significant link to a higher risk of stomach cancer. For female participants, however, eating both processed meat and white meat was linked to an increased risk.
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These findings align with global health benchmarks, particularly those established by the World Health Organization’s International Agency for Research on Cancer.
The agency has long classified processed meat as a known human carcinogen, primarily due to its strong, well-documented links to colorectal cancer.
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However, health organizations have also consistently pointed to a potential, yet less definitive, relationship between these meats and cancers of the stomach.
Eating 30 grams of processed meat a day, or the equivalent to one slice of ham, was linked to a 13% higher risk of esophageal adenocarcinoma. (iStock)
Further scientific investigation is needed to confirm the findings and to account for other underlying risk factors, such as certain stomach infections, which could interact with dietary habits.
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A key limitation of the study is its reliance on self-reported diets, which can sometimes lead to inaccuracies in how participants recall their meat consumption over time, the researchers noted.
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The findings were published in the International Journal of Cancer.
Fox News Digital reached out to the researchers requesting comment.
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