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Pharmaceutical industry

FDA Approves New Weight Loss Drug, Liraglutide, Amid Concerns Over Cost and Safety

Strategic Insights

— 2 min read

Liraglutide, a daily injectable drug, has been approved by the FDA for weight loss in obese patients and those with weight-related health issues. The new prescription, Saxenda, is specifically designed for this purpose, and its approval marks a significant development in the treatment of obesity, a major public health issue. However, concerns over the cost and safety of liraglutide have been raised, given the historical checkered record of diet drugs.

Key Takeaways:

  • Liraglutide, sold under the brand name Saxenda, is a daily injectable drug approved for weight loss in obese patients and those with weight-related health issues.
  • The new prescription is specifically designed for this purpose, and its approval marks a significant development in the treatment of obesity, a major public health issue.
  • The FDA considers a drug effective if it enables a 5 percent weight loss when combined with diet and exercise.
  • However, for people 30 percent over healthy weight - obese - this effect may be a letdown, as they may remain obese after losing weight.
  • Industry reports suggest the cost of Saxenda may be as high as $9,000 per year, which may be a barrier to its adoption.
  • Saxenda's main side effects were nausea, diarrhea, and vomiting, but these symptoms typically went away within days.
  • Long-term safety remains a concern, with the FDA requiring post-marketing studies to evaluate cardiovascular effects, breast cancer, and thyroid cancer risks.
  • Liraglutide works primarily by imitating a molecule that the body produces to stimulate insulin release, and it slows the passage of food from the stomach to the small intestine, bolstering the "I'm full" signal in the brain.
  • A clinical trial of over 3,700 patients found that 64% taking Saxenda for a year lost at least 5% of their weight, and 33% lost at least 10%.
  • A follow-up trial found that patients who lost weight on Saxenda continued to lose weight during a second year on the medication.

Statistics:

  • 80 million people in the United States are suffering from obesity (Cherie L. Vaz, endocrinologist at Temple University School of Medicine).
  • 5% weight loss is considered effective by the FDA when combined with diet and exercise.
  • 64% of patients taking Saxenda for a year lost at least 5% of their weight in a clinical trial.
  • 33% of patients taking Saxenda for a year lost at least 10% of their weight in a clinical trial.
  • $9,000 per year is the estimated cost of Saxenda, according to industry reports.
  • 3,700 patients participated in a clinical trial of Saxenda.
  • 27% of patients in the placebo group had a 5% weight loss, and 10% had a 10% weight loss in a clinical trial.

Sources:

  • The Philadelphia Inquirer
  • Cherie L. Vaz, endocrinologist at Temple University School of Medicine
  • Thomas Wadden, director of the Center for Weight and Eating Disorders at the University of Pennsylvania School of Medicine
  • Matthew R. Hayes, Penn nutritional neuroscientist
  • Novo Nordisk, a Danish pharmaceutical company with U.S. headquarters in Princeton
  • Einstein Healthcare Network, based in Elkins Park
  • The FDA
  • Tribune Content Agency, LLC

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