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Obesity drug

Belviq approved in the US

Indication includes reduced-calorie diet and increased physical activity
Companies to carry out post marketing studies
Belviq (lorcaserin hydrochloride)

The FDA has approved Belviq (lorcaserin hydrochloride), the first obesity drug to be approved in over ten years.  Marketed in the US by Eisai and manufactured in Switzerland by Arena Pharmaceuticals, Belviq is believed to decrease food consumption and promote satiety by selectively activating serotonin 2C receptors in the brain.

“Obesity threatens the overall well-being of patients and is a major public health concern,” said Dr Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. “The approval of this drug, used responsibly in combination with a healthy diet and lifestyle, provides a treatment option for Americans who are obese or are overweight and have at least one weight-related comorbid condition.”

Belviq is indicated to be used along with a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of:

  • BMI>30 or greater or
  • BMI>27 or greater in the presence of at least one weight related comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes)

Clinical programme

The Belviq Phase 3 clinical trial programme consisted of three double-blind, randomised, placebo-controlled trials: BLOOM (Behavioral modification and Lorcaserin for Overweight and Obesity Management), BLOSSOM (Behavioral modification and LOrcaserin Second Study for Obesity Management) and BLOOM-DM (Behavioral modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus).

All three trials included a standardized program of diet, moderate exercise and behavioural counselling for both the placebo and Belviq groups.

BLOOM evaluated Belviq versus placebo over a two-year treatment period in 3,182 non-diabetic, obese adult patients (18 to 65 years old) with or without comorbid conditions and non-diabetic, overweight adult patients with at least one weight related comorbid condition.

BLOSSOM evaluated Belviq versus placebo over a one-year treatment period in 4,008 non-diabetic, obese adult patients (18 to 65 years old) with or without comorbid conditions and non-diabetic, overweight adult patients with at least one weight related comorbid condition.

BLOOM-DM evaluated Belviq versus placebo over a one-year treatment period in 604 obese and overweight adult patients (18 to 65 years old) with type 2 diabetes who were receiving oral antihyperglycemic agents.

The outcomes showed that Belviq along with diet and exercise was more effective than diet and exercise alone at helping patients lose 5% or more of their body weight after one year and managing the weight loss for up to two years.

The most common adverse reactions for patients without diabetes treated with Belviq were headache, dizziness, fatigue, nausea, dry mouth, and constipation. In patients with diabetes, the most common adverse reactions were hypoglycemia, headache, back pain, cough, and fatigue.

Post-marketing studies

 As part of the approval procedure for Belviq, the companies committed to conduct post-marketing studies to assess the safety and efficacy of Belviq for weight management in obese pediatric patients, as well as to evaluate the effect of long-term treatment with Belviq on the incidence of major adverse cardiovascular events in overweight and obese subjects with cardiovascular disease or multiple cardiovascular risk factors. The cardiovascular outcomes trial will include echocardiographic assessments.

The FDA has recommended that Belviq be classified as a scheduled drug. The DEA will review the FDA's recommendation and determine the final scheduling designation. Once the DEA has provided the final scheduling designation, Eisai will announce when Belviq will be available to patients and physicians in the United States.

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