The new obesity drug lorcaserin (Belviq, Eisai/Arena Pharmaceuticals) will finally be available for prescription in the United States next week, the manufacturers have announced. The news comes as the European regulatory agency provides more details about why it rejected the product.
Lorcaserin, which was cleared for marketing in the United States almost a year ago in its second attempt, is indicated for chronic weight management, along with a calorie-controlled diet and increased physical activity, in adults with a body mass index (BMI) of 30 kg/m2 more or in those with a BMI of 27 kg/m2 or more who have at least 1 weight-related medical condition, such as type 2 diabetes or high blood pressure.
Lorcaserin is a 5HT2c-receptor agonist, which is believed to imitate the effects of serotonin on these receptors, resulting in an increased sense of fullness after a meal and reduced hunger before meals, thereby reducing food consumption.
It will be the second obesity drug to appear on the US market in recent times; Qsymia (phentermine/topiramate; Vivus) was the first new obesity medication in 13 years when it was launched last September. Sales of Qsymia have been slow, however, and it will be interesting to see how lorcaserin is received.
The delay in launching lorcaserin in the United States was due to the companies waiting for regulatory classification to determine the risk of abuse; this came recently when the Drug Enforcement Agency deemed it was a schedule IV drug — the second-least-restrictive designation on a 5-step scale.
EMA Says Benefits Do Not Outweigh Risks for Lorcaserin
The European Medicines Agency (EMA), however, has not seen fit to give the thumbs up to lorcaserin; Arena Pharmaceuticals withdrew its application for European Union approval for the product last month.
The EMA has since revealed that it was concerned about the potential risk for tumors, particularly with long-term use, based on the results of laboratory tests. It also had other safety concerns, including the potential risk of psychiatric disorders (such as depression) and valvulopathy, which were seen in some patients during clinical trials.
The cancer risk in animal studies was one of the concerns of the Food and Drug Administration (FDA) when it rejected lorcaserin the first time around.
The EMA says it is still "of the opinion that the benefits of Belviq did not outweigh its risks."
Arena decided to withdraw the EU application because it could not resolve the European agency's "major objections related to the results of nonclinical studies within the regulatory timeframe." The future development strategy for lorcaserin in Europe "is under evaluation," the company says.
Medscape Medical News © 2013 WebMD, LLC
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Cite this: Lisa Nainggolan. New Obesity Drug, Belviq, in US Pharmacies Next Week - Medscape - Jun 07, 2013.