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FDA Approves Eli Lilly’s Zepbound for Sleep Apnea, Expanding its Use in the U.S.

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The U.S. Food and Drug Administration (FDA) has approved Eli Lilly’s weight loss drug, Zepbound, for treating moderate-to-severe obstructive sleep apnea (OSA), the most common sleep-related breathing disorder. This approval marks the first drug treatment option for patients with both obesity and OSA, which is characterized by breathing interruptions during sleep due to blocked or narrowed airways. Zepbound, a weekly injection, should be used alongside a reduced-calorie diet and increased physical activity, the FDA stated.

An estimated 80 million people in the U.S. are affected by OSA, with about 20 million suffering from the moderate-to-severe form of the disorder. Alarmingly, 85% of these cases remain undiagnosed, according to Eli Lilly.

Julie Flygare, president and CEO of Project Sleep, a nonprofit focused on sleep health, emphasized that OSA is more than just snoring, urging for greater awareness and conversation about the condition. She expressed hope that Zepbound’s approval would lead to better health outcomes through more informed discussions between patients and healthcare providers.

The approval expands Zepbound’s use beyond obesity treatment, which it was first approved for late last year. The drug’s active ingredient, tirzepatide, is also marketed as Mounjaro, a diabetes treatment. Eli Lilly expects to launch Zepbound for OSA in early 2025 and is also testing the drug for other obesity-related conditions such as fatty liver disease.

Zepbound’s approval may help secure broader insurance coverage, which is a challenge for many weight loss drugs, including Zepbound itself. Current coverage under Medicare for obesity treatments depends on their approval for additional health benefits, like treating OSA.

Zepbound’s approval also highlights the growing body of evidence supporting the health benefits of GLP-1s, a class of medications used for weight loss and diabetes management. Zepbound’s main competitor, Novo Nordisk’s Wegovy, is not approved for OSA.

The new approval provides a significant option for OSA patients who often rely on cumbersome positive airway pressure (PAP) machines to help with breathing. Zepbound offers a more convenient alternative with the potential to resolve OSA symptoms.

In clinical trials, Zepbound demonstrated significant effectiveness in reducing OSA severity. A year-long study showed that Zepbound was more effective than a placebo, with nearly half of patients achieving disease resolution. Zepbound resolved OSA in 43% of patients who were not using PAP therapy and 51.5% of those continuing PAP therapy. This compares to only 13.6% to 14.9% of placebo recipients in the same trials.

The results were based on the apnea-hypopnea index (AHI), which measures the number of blocked or restricted breaths per hour, and used to assess both the severity of OSA and the effectiveness of treatments. Disease resolution is defined as having fewer than five AHI events per hour or a significant reduction in daytime sleepiness, according to Eli Lilly.

 

Indian Junior Doctors Continue Protests After Colleague’s Rape and Murder, Demand Stronger Protections

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Junior doctors in India are continuing their protests and refraining from non-emergency work after the brutal rape and murder of a 31-year-old postgraduate medical student in Kolkata. The incident, which occurred in the early hours of August 9 at the R.G. Kar Medical College and Hospital, has sparked outrage across the country, leading to a series of strikes, candlelight marches, and demands for justice from the medical community and women’s rights activists.

The Indian Medical Association (IMA), the country’s largest association of doctors, called for a 24-hour strike that ended on Sunday morning, yet many junior doctors are still off the job, particularly in Modi’s home state of Gujarat, where over 6,000 trainee doctors have continued their protest. These doctors are providing emergency services but have withdrawn from routine outpatient and ward work, pushing for increased security measures in hospitals to protect healthcare workers, particularly women, who make up 60% of India’s medical workforce.

The victim’s father expressed his sorrow but found solace in the widespread support from the medical community, which has united in the face of this tragedy. The incident has reignited discussions about the safety of women in India, despite the introduction of tougher laws following the infamous 2012 Delhi gang-rape and murder case. Activists argue that while laws have changed, the underlying culture of violence against women persists, and more needs to be done to ensure their safety.

The IMA has urged Prime Minister Narendra Modi to intervene, emphasizing the need for hospital security protocols similar to those in airports to protect medical professionals. The government’s response has been to urge doctors to return to duty, particularly in light of rising cases of dengue and malaria, and to set up a committee to explore enhanced protection measures for healthcare workers.

Despite this, the All India Residents and Junior Doctors’ Joint Action Forum has vowed to continue its “nationwide cease-work” until a thorough investigation is conducted and arrests are made. The protests have put significant strain on medical facilities, especially in Kolkata, where the R.G. Kar hospital has been the epicenter of the agitation. Authorities have responded by banning gatherings around the hospital and deploying police in riot gear to maintain order.

As the protests continue, the medical community remains steadfast in its demands for justice and safer working conditions, underscoring the urgent need for systemic changes to protect those who care for the nation’s health.

Merck Shares Fall 9% Despite Earnings Beat and Strong Demand for Key Drugs

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Merck reported second-quarter revenue and adjusted earnings that exceeded Wall Street’s expectations, driven by strong sales from its blockbuster cancer drug Keytruda and other treatments in its oncology and vaccines portfolios, as well as a newly launched cardiovascular drug. Despite this, Merck’s shares fell by 9% due to lighter-than-expected sales of Gardasil, a vaccine for HPV, exacerbated by shipment issues in China.

Merck raised its full-year sales forecast to $63.4 billion to $64.4 billion, slightly up from its previous guidance of $63.1 billion to $64.3 billion. However, it lowered its adjusted profit guidance to a range of $7.94 to $8.04 per share, down from $8.53 to $8.65 per share, reflecting one-time charges for its acquisitions of Harpoon Therapeutics and EyeBio.

For the second quarter, Merck reported adjusted earnings per share of $2.28, surpassing the expected $2.15, and revenue of $16.11 billion, above the anticipated $15.84 billion. The company posted a net income of $5.46 billion, or $2.14 per share, compared to a net loss of $5.98 billion, or $2.35 per share, in the same period last year.

Keytruda recorded $7.27 billion in revenue, up 16% year-over-year, driven by higher uptake for earlier-stage cancers and strong demand for metastatic cancers. Gardasil sales increased by only 1% to $2.48 billion due to shipment timing issues in China. Winrevair, approved in March for treating a progressive lung condition, posted $70 million in revenue, while Capvaxive, a newly approved pneumococcal vaccine, is expected to drive future growth.

Merck’s pharmaceutical division saw a 7% increase in revenue to $14.41 billion. The company’s Type 2 diabetes treatment, Januvia, faced a 27% decline in sales to $629 million due to lower demand, prices, and generic competition. Sales of Merck’s Covid antiviral pill, Lagevrio, fell by 46% to $110 million but still exceeded expectations.

Merck’s animal health division reported $1.48 billion in sales, up 2% from the previous year, but slightly below analyst expectations. Despite strong overall performance, investor concerns about Gardasil sales and future challenges in the pharmaceutical landscape influenced the decline in Merck’s stock.