Yazılar

Apple Watch gains AI-powered high blood pressure notification feature

Apple unveiled a new AI-driven health feature for the Apple Watch Series 11, launching Friday, that can notify users if they may have high blood pressure. The notification tool, approved by the U.S. Food and Drug Administration, will also roll out to Apple Watch Series 9 and later models in over 150 countries.

Unlike a traditional blood pressure cuff (sphygmomanometer), the Watch does not measure blood pressure directly. Instead, Apple used machine learning to analyze sensor data from its large-scale Heart and Movement Study, launched in 2019 with 100,000 participants. Researchers identified patterns in the watch’s heart-related signals and validated the resulting algorithm in a dedicated study of 2,000 people.

The feature is designed to prompt users to check their blood pressure with a cuff and consult a doctor if alerts appear. Apple Vice President of Health Sumbul Ahmad Desai emphasized that the company has long pursued ways to detect hypertension, a condition affecting over 1 billion people worldwide, half of whom remain undiagnosed.

Cardiology expert Ami Bhatt called the rollout significant, noting it could help reduce risks of heart attacks, strokes, and kidney disease by prompting early detection. Still, she cautioned that the tool is not a replacement for professional diagnosis and carries risks of both false positives and false reassurance for those who don’t receive alerts.

The addition highlights Apple’s broader push into preventive healthcare, positioning the Watch as not only a fitness tracker but also an early-warning tool for chronic conditions.

Generic Version of Liraglutide Approved, Offering Lower-Priced GLP-1 Option

The U.S. Food and Drug Administration (FDA) recently approved a generic version of the daily injectable GLP-1 medication liraglutide for the treatment of type 2 diabetes. This approval opens the door for more affordable options, helping to address an ongoing shortage of the drug. Liraglutide, sold under the brand name Victoza, is in the same class as semaglutide, the active ingredient in Ozempic, both of which are marketed by Danish pharmaceutical giant Novo Nordisk.

The generic version of liraglutide will be produced by Hikma Pharmaceuticals USA, which plans to make it available nationwide by the end of the year. While the company did not disclose the exact price, it confirmed that the generic would be priced lower than the branded version, which can range from $500 to $815 per package, depending on dosage.

According to Dr. Harlan Krumholz, a cardiologist at Yale University, the availability of the generic will benefit many patients currently using liraglutide. However, he points out that newer GLP-1 medications, such as Ozempic, Wegovy, Mounjaro, and Zepbound, which are given as weekly injections, have shown stronger benefits, particularly for patients with obesity. These medications, which cost upwards of $1,000 per month without insurance, are not yet available as generics, which may create a two-tier system in which lower-income patients only have access to drugs with less robust evidence of effectiveness.

In addition to this new generic, Teva Pharmaceuticals had introduced an authorized generic version of liraglutide in June 2024, as part of a settlement with Novo Nordisk. The authorized generic is priced about 14% lower than branded Victoza but is identical in formulation, produced by Novo Nordisk and distributed by Teva.

While authorized generics are essentially branded drugs sold without the brand name, true generic drugs like the newly approved liraglutide are manufactured by other companies and are designed to be more affordable alternatives. The FDA has emphasized that generics provide patients with additional, more cost-effective treatment options, especially for drugs in shortage.

Experts, including Dr. Aaron Kesselheim from Harvard Medical School, caution that it often takes multiple generic manufacturers entering the market before prices significantly drop. Typically, prices may decrease by 50-60% when four or more generics are available. However, the approval of the first generic liraglutide marks a positive step toward more competitive pricing in the market.

Liraglutide has been in shortage in the U.S. since July 2023, with the FDA prioritizing the assessment of generic drug applications for drugs in shortage to improve patient access. Dr. Jody Dushay, an endocrinologist at Beth Israel Deaconess Medical Center, expressed hope that the generic version will be significantly cheaper than the brand-name drugs and that it will quickly become available to patients.

 

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

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.