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lorcaserin approval
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1. The overview of lorcaserin
Belviq (lorcaserin hydrochloride) is a serotonin 2C receptor agonist for oral administration used for chronic weight management. It has been shown to decrease food consumption and promote satiety by selectively activating serotonin 2C receptors in the brain.
2. Lorcaserin approval
Lorcaserin hydrochloride, indicated for weight management in patients who are obese or overweight, in addition to a reduced-calorie diet and exercise, was approved on June 27, 2012 by the FDA in a landmark decision after 2 years of scrutiny.
3. Background:
In 1997, fenfluramine and dexfenfluramine were taken off the market following evidence that the weight loss drugs caused heart valve damage. This effect is thought to be related to activation of the serotonin 2B receptor on heart tissue.
On 22 December 2009 a New Drug Application (NDA) was submitted to the Food and Drug Administration (FDA) in the United States. On 16 September 2010, an FDA advisory panel voted to recommend against approval of the drug based on concerns over both safety and efficacy. This was an item of concern when it came time for the FDA’s Endocrinologic and Metabolic Drug Advisory Committee to review the drug application on October 1, 2010.
On 10 May 2012, after a new round of studies submitted by Arena, an FDA panel voted to recommend lorcaserin with certain restrictions and patient monitoring. The restrictions include patients with a BMI of over 30, or with a BMI over 27 and a comorbidity like high blood pressure or type 2 diabetes.
On 27 June 2012, the FDA officially approved lorcaserin for use in the treatment of obesity for adults with a BMI equal to or greater than 30 or adults with a BMI of 27 or greater who "have at least one weight-related health condition, such as high blood pressure, type 2 diabetes, or high cholesterol". Hence, lorcaserin fda approval finally had been done.
Verified Supplier
HANGZHOU HOLYPHARM BIOTECH CO.,LTD
- Country:
China (Mainland) - Year Established: 2009
- Business License:
- Business type: Other
- Integral:
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