FDA approves Eli Lilly’s obesity medication for obstructive sleep apnea
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(NEW YORK) — The FDA has expanded the approval of Eli Lilly’s obesity medication Zepbound to include treating moderate to severe obstructive sleep apnea for people with obesity — the first medication approved for the condition.
The new, expanded Zepbound approval means that insurance providers, including Medicare, will likely cover the medication for people with sleep apnea and obesity. Some insurance providers, including Medicare, do not offer reimbursement to treat obesity alone.
The new approval is for people with moderate to severe obstructive sleep apnea who are also living with obesity. Eli Lilly estimates that is about 15-20 million adults in the U.S.
Obstructive sleep apnea isn’t just an inconvenience, it’s a serious medical condition that impairs breathing and sleep quality. Obesity and obstructive sleep apnea are linked. People tend to see their obstructive sleep apnea get better when they lose a significant amount of weight. It’s likely the weight loss associated with the medication is helping improve the sleep apnea.
Right now, there is no medicine to treat obstructive sleep apnea — it’s only treated with a positive airway pressure device.
In a study, people who took Zepbound had at least 25 fewer breathing interruptions per hour while they slept. They also lost an average of 20% of their body weight.
The study also followed people over a year, and found that up to half of the adults taking Zepbound no longer had obstructive sleep apnea symptoms at the end of the year.
Obstructive sleep apnea is more common in men than women. Up to 34% of U.S. men have OSA compared to 17% of U.S. women, according to the American Academy of Family Physicians.
Common signs of sleep apnea include heavy snoring at night, long pauses in breathing while sleeping as well as excessive daytime sleepiness, forgetfulness and morning headaches. The symptoms of the disorder can lead to significant medical problems.
After more than two years of gender-affirming treatments, LW, the Tennessee teenager behind a landmark case at the U.S. Supreme Court, says, “I feel normal now.” (ABC News)
(NASHVILLE) — The transgender Tennessee teenager behind a historic hearing at the U.S. Supreme Court this week doesn’t want to show her face on television but is eager to speak about a case she says has the potential to make thousands of American kids feel “seen” for who they are.
“The court has definitely ruled in ways that would make me think that they don’t exactly value bodily autonomy, but I have heard that they’ve been a little bit better about trans cases than people would think,” said 16-year-old LW in an exclusive interview with ABC News alongside her parents Samantha and Brian Williams.
The court on Wednesday will hear the Williams family’s challenge to Tennessee’s 2023 ban on gender-affirming medical treatments for minors, including puberty-blocking medication and hormone therapies that have dramatically improved LW’s quality of life.
While the medications have been used safely to treat minors of all genders for years, they are now prohibited in Tennessee when used to treat trans kids struggling with gender dysphoria, the distress experienced when one’s gender assigned at birth is different from one’s sense of identity.
“It’s not very comfortable being trapped in [your body] because it just doesn’t feel like you,” said LW, who reports significant improvement since beginning the treatments in 2022.
Since the state law took effect, LW now has to take time away from school to make a 10-hour round trip out of state to continue receiving care. The travel has also been a costly and time-consuming burden, her parents say.
“It would definitely be horrible for me to have to continue to go out of state to get care,” said LW. “I feel normal now.”
Backed by the American Civil Liberties Union, the Biden administration, and major American medical associations, the Williamses sued Tennessee last year alleging the ban on certain gender-affirming treatments for minors discriminates on the basis of sex and overrides the rights of parents to make medical decisions for their children.
“Our state legislature had made such a big deal out of parents’ rights during COVID, about masks and vaccines that that’s for parents to decide these medical decisions for their children,” Samantha Williams said. “And then they made this medical decision for our child.”
State lawmakers who support the law, SB1, say it is meant to protect kids from potentially irreversible effects from treatment and that contradictory scientific evidence and uncertainty about long-term adverse consequences warrant caution.
“We made the policy decision on behalf of our constituents that in Tennessee we think this is a risky procedure,” said state Sen. Jack Johnson, the Senate GOP leader who sponsored the bill. “It is our role as policymakers here in the state of Tennessee to set those guardrails.”
The American Academy of Pediatrics says the effects of puberty blockers are not permanent if treatment is discontinued and that many effects of hormone therapy can also be reversed. Long-term risks may include fertility challenges and possible harm to bone density, but the Academy says those risks require further study.
Worldwide, several countries which had previously embraced the treatments for transgender children have subsequently reversed course, citing unclear data about their purported benefits and alleged harms. In many of those places, the treatments remain available, but on a much more limited basis.
In Tennessee, there are an estimated 3,000 transgender teenagers between ages 13 and 17, according to the Williams Institute at UCLA Law School, which has analyzed Census data. It is not known how many were receiving treatments that are now outlawed or how many suffered alleged harm.
A study published in the medical journal JAMA Pediatrics in October 2024 found the overwhelming majority of participants in a long-term survey of 220 transgender youths reported high levels of satisfaction and low levels of regret in the three to five years after receiving puberty blockers and hormone therapy.
Major American medical associations have for more than a decade endorsed the use of puberty blockers and hormone therapy as part of “individually tailored interventions” to support trans kids and affirm their sense of self.
“It all begins and ends with science. This is not about any sort of agenda,” said Dr. Ben Hoffman, president of the American Academy of Pediatrics, in an interview with ABC.
Clinical practice guidelines from the American Endocrine Society — based on more than 260 research studies — recommend consideration of medications to treat gender dysphoria in young people but waiting until a child reaches adulthood to consider gender-affirming surgery.
“It’s crucial that there be a deep understanding of both the risks and benefits, and truly informed consent,” Hoffman said. “And for that reason, it is, by definition, going to take months or years.”
The Williams family said the decision to use medication to delay LW’s puberty followed months of careful consultation with medical experts and mental health providers. They said they grew worried that masculine changes to LW’s body would compound her gender dysphoria.
“There is this time clock sitting here,” said Brian Williams. “The kids can go through puberty and it can have permanent effects on them. So these two things you’re trying to balance at the same time.”
“She’s not suicidal, but she shouldn’t have to be suicidal, right?, to get the care that she needs,” added Samantha Williams. “When that really hit me, I was like, ‘OK, let’s do blockers. Let’s get moving.'”
More than a year later, LW began receiving hormone therapy to better align her body with her gender identity. The course of treatment led to a reduction in discomfort.
“That was incredibly helpful,” LW said. “I feel amazing after that. You know, maybe it’s just because the gender dysphoria was so bad.”
The outcome of the case U.S. v. Skrmetti could have a sweeping impact on health care for the more than 300,000 American teens who identify as transgender, as well as the broader LGBTQ community.
“This is one of the most significant LGBTQ cases to ever reach the Supreme Court. I think this is an inflection point,” said Chase Strangio, the ACLU attorney representing the Williams family. He will be the first openly transgender person to argue a case before the nation’s highest court.
“Is this going to be a Bowers v. Hardwick type moment that sets off years of government legitimized discrimination against LGBTQ people? Or, is this going to be a Bostock moment that clarifies what we all have been assuming all this time, which is that LGBTQ people are protected under the Constitution and civil rights laws,” Strangio said.
In its 1968 decision in Bowers, the court upheld state laws criminalizing private same-sex conduct; it was overturned in 2003. The Court’s 2020 decision in Bostock v. Clayton County found that employment discrimination on the basis of sexual orientation and gender identity is illegal.
Twenty-six states have laws banning gender-affirming treatments for minors, according to the Human Rights Campaign, an LGBTQ advocacy group.
“What concerns me as a physician is that legislators are going to be able to make decisions about a diagnosis, which is very unusual. I mean, that really hasn’t happened,” said Dr. Susan Lacy, a physician who specializes in hormone management and transgender care for teens and adults at her private practice in Memphis.
Lacy, who is also a party to the Supreme Court case, agrees with Tennessee lawmakers that more research is needed on gender-affirming treatments for minors, but that a debate over the data shouldn’t deny patients the chance to make an informed decision of their own.
“I think the most compelling thing is to listen to the patients,” Lacy said. “I have about 700 transgender patients out of about 3,000 total patients, and I have not seen anybody have a serious complication — not one.”
“I think we’re just at a point where we’re still in the process of treating people and having studies that will give us more and more data to support this treatment,” she said.
Johnson said he hopes the Supreme Court will uphold an appeals court ruling that affirmed Tennessee’s right to impose restrictions on treatments for transgender minors.
“States should be the laboratories of democracy,” he said. “We should be making the vast majority of decisions about what’s best for our people, our constituents here in the statehouse.”
The Williams family says care that has improved the life of their daughter should not be up for political debate.
“I want to listen to the doctors. I want to listen to my kid. I want to take care of her, you know?” Brian Williams said.
(NEW YORK) — The U.S. Food and Drug Administration (FDA) on Thursday approved a new type of prescription pain medication for adults to treat moderate to severe acute pain.
The drug, called Journavx (suzetrigine) and manufactured by biotech company Vertex Pharmaceuticals, is a non-opioid painkiller, which doesn’t have addictive properties, unlike opioids often used for this type of pain.
This is the first class of non-opioid pain medication approved to treat moderate to severe acute pain approved by the FDA in more than 20 years.
“Today’s approval is an important public health milestone in acute pain management,” said Dr. Jacqueline Corrigan-Curay, acting director of the FDA’s Center for Drug Evaluation and Research, in a press release. “A new non-opioid analgesic therapeutic class for acute pain offers an opportunity to mitigate certain risks associated with using an opioid for pain and provides patients with another treatment option.”
In two clinical trials, tested on adults between ages 18 and 80, Journavx was found to reduce moderate to severe acute pain for adults from baseline by about 50% in 48 hours.
The average time to meaningful pain relief ranged from two to four hours, compared to eight hours in the placebo group.
Journavx works by inhibiting the NaV1.8 pain signal in the peripheral nervous system. This channel is not expressed in the brain or anywhere else in the central nervous system, therefore the drug does not have addictive properties like opioids, according to Vertex.
Journavx was found to be as similarly effective as hydrocodone, an opioid pain medication, for reducing acute pain, with the added benefit of being a non-opioid and non-addictive drug.
In another clinical trial, the drug was tested in patients with a broader range of surgical and non-surgical acute pain conditions and was found to be safe and effective.
More than 80% of patients in this clinical trial rated Journavx as a good, very good or excellent pain medication when investigating multiple acute pain types.
The new drug “offers a safer option for managing moderate-to-severe acute pain, reducing reliance on opioids,” Dr. Jianguo Cheng, a professor of anesthesiology and medical director of the Cleveland Clinic Consortium for Pain at Cleveland Clinic, who was not involved in the clinical trials, told ABC News. “It offers rapid relief and can be integrated into postoperative pain protocols or acute pain scenarios where immediate relief is critical.”
“By managing acute pain effectively, [Journavx] may help prevent the transition to chronic pain, reducing the need for long-term pain management strategies,” he added.
(NEW YORK) — More than 1 million children may have been affected by long COVID in 2023, new federal data published Monday suggests.
Long COVID, a condition that occurs when patients still have symptoms at least three months after clearing infection, has been well-documented in adults, but its impact on children has been less clear.
Researchers from two divisions within the Centers for Disease Control and Prevention looked at results from the 2023 National Health Interview Survey, a nationwide survey that monitors the health of the U.S. population.
One child aged 17 or under was randomly selected from each sample household within the survey, and parents responded to questions about whether their child had previous COVID-19 illness, if the child had symptoms lasting three months or longer and if the child still had those symptoms at the time of interview.
Results of the analysis, published in the journal JAMA Pediatrics, showed approximately 1.01 million children, or 1.4%, are believed to have ever experienced long COVID in 2023 and about 293,000, or 0.4%, were experiencing the condition when the survey was being conducted.
This is similar to the 1.3%, or about 1 million, of children ever estimated to have had long COVID in 2022, according to the authors.
Children between ages 12 and 17 were most likely to have ever experienced long COVID or to still have the condition. Long COVID prevalence was also higher among Hispanic and non-Hispanic white children compared to non-Hispanic Black and Asian children.
Long COVID was also most common among children with a family income of under $100,000 and of parents with an education level of an associate’s degree or less.
Among children currently experiencing long COVID at the time of interview, 80% reported to have some level of activity limitation compared with before they had COVID-19.
“The large proportion of children experiencing [long COVID] with any activity limitation highlights the need to examine the severity of activity limitation, functional outcomes, and days lost from school,” the authors wrote.
The authors said there may be an under-reporting of long COVID in younger children due to difficulty with the verbalization of their symptoms.
Long COVID most often occurs in people who had severe illness, but anyone can develop the condition, according to the CDC. People who are not vaccinated against COVID-19 are at higher risk of developing long COVID, the agency says.
Scientists are not sure what causes long COVID but have identified risk factors including having underlying conditions.