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

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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.

 

Merck Signs $2 Billion Licensing Deal for Weight Loss Pill with Chinese Drugmaker Hansoh Pharma

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Merck announced on Wednesday that it has secured the rights to an experimental weight loss pill from Chinese drugmaker Hansoh Pharma in a deal worth up to $2 billion. This oral drug, currently not in human trials, could position Merck to capitalize on the rapidly expanding obesity drug market, which analysts predict could exceed $100 billion annually by the early 2030s.

While Merck did not specify the diseases it plans to target first with this drug, the deal significantly boosts its potential in the obesity treatment field. The move comes as several other pharmaceutical companies, including Pfizer and Roche, are working to develop competitive oral weight loss medications that can challenge the blockbuster injectable drugs from Novo Nordisk and Eli Lilly.

Under the terms of the agreement, Merck will receive exclusive global rights to develop, manufacture, and commercialize Hansoh Pharma’s HS-10535, an oral drug targeting GLP-1, a gut hormone. GLP-1 is the same target for Novo Nordisk’s popular weight loss drug Wegovy and diabetes medication Ozempic, which work by suppressing appetite and regulating blood sugar levels.

Merck will pay Hansoh Pharma an upfront fee of $112 million for the licensing rights to the drug. Additionally, the deal includes up to $1.9 billion in milestone payments and royalties on future sales, according to a press release from the company.

Merck’s president of Research Laboratories, Dean Li, expressed confidence in the drug’s potential, noting it could offer “additional cardiometabolic benefits beyond weight reduction.” The company has been actively seeking GLP-1 treatments that provide not just weight loss but other health benefits, such as improvements in cardiovascular health, diabetes, and fatty liver disease. Merck CEO Rob Davis highlighted this strategic focus in early 2023, stating that therapies with broader health benefits would be crucial for obtaining reimbursement and establishing long-term market success.

This agreement with Hansoh Pharma adds to the growing trend of Chinese companies entering the global market for GLP-1-based treatments. In a similar deal last year, AstraZeneca licensed an experimental oral GLP-1 drug from Chinese company Eccogene, which is currently in mid-stage development.

 

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.