The Food and Drug Administration has approved a Novo Nordisk diabetes drug as a treatment for obesity. It's the first Injectible drug approved for weight loss.
The drug, liraglutide, will be marketed under the brand name Saxenda. It is approved for obese adults and for overweight adults who have at least one weight-related health problem like type 2 diabetes, high blood pressure, or high cholesterol.
The agency on Tuesday approved Saxenda (liraglutide) for adults who are obese or for those who are overweight and have at least one weight-related health condition, such as high blood pressure, type 2 diabetes or high cholesterol.
"Obesity is a public health concern and threatens the overall well-being of patients," Dr. James Smith, acting deputy director of the division of metabolism and endocrinology products in the FDA's Center for Drug Evaluation and Research, said in an agency news release.
"Saxenda, used responsibly in combination with a healthy lifestyle that includes a reduced-calorie diet and exercise, provides an additional treatment option for chronic weight management for people who are obese or are overweight and have at least one weight-related comorbid condition," Smith said.
The FDA has approved three weight loss pills in recent years. It cleared Vivus Inc.'s Qsymia and Arena Pharmaceuticals Inc.'s Belviq in 2012 and granted approval to Orexigen Therapeutics Inc.'s drug Contrave in September. While analysts initially expected great demand for those drugs, sales fell far short of expectations because of limited insurance coverage and high out-of-pocket costs for patients.
The FDA added that patients should be examined to determine if Saxenda is working after 16 weeks of treatment. Those who do not lose at least 4 percent of their body weight by that time should stop taking the medication, the FDA said.
The FDA has also required that additional studies involving Saxenda investigate the safety and effectiveness of the drug in children, including how it could affect growth and development.
The FDA also required that an MTC case registry be established to identify any possible increase in cases associated with Saxenda use over a minimum of 15 years. Ongoing clinical trials are also examining the possible risk of breast cancer associated with Saxenda.
