BELVIQ is approved by the US Food and Drug Administration for use as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30 kg/m2 or greater (obese), or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes). The indication includes the following limitations of use: The safety and efficacy of coadministration of BELVIQ with other products intended for weight loss and the effect of BELVIQ on cardiovascular morbidity and mortality have not been established.
We have granted exclusive marketing and distribution rights for BELVIQ to Eisai for all countries worldwide, except for South Korea, Taiwan, Australia, Israel and New Zealand, to Ildong for South Korea and to CY Biotech for Taiwan. In addition, we intend to enter into additional collaborations to support the commercialization of BELVIQ in the remaining territories. We have composition of matter patents for BELVIQ issued in most major jurisdictions globally that, in most cases, are capable of continuing into 2023. With respect to the United States, we have filed applications for patent extension, which, if granted, will extend the patent term for BELVIQ into 2026.
BELVIQ is believed to decrease food consumption and promote satiety by selectively activating serotonin 2C receptors in the brain. Activation of these receptors may help a person eat less and feel full after eating smaller amounts of food. The exact mechanism of action is not known.
BELVIQ is approved by the US Food and Drug Administration and will be available in the US only after its Schedule IV designation is effective on June 7, 2013.
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