Japanese pharmaceutical company Eisai has received the US Food and Drug Administration (FDA) approval for a new drug application (NDA) for Belviq XR, used for chronic weight management.
Slated to be launched in the US market in autumn this year, Belviq XR is a sustained release formulation of lorcaserin hydrochloride that needs to be taken once every day by the patient.
Go deeper with GlobalData
Lorcaserin hydrochloride has been discovered and developed by US-based Arena Pharmaceuticals, and is an effective chemical entity that can reduce food consumption in a person and cause satiety by selectively activating serotonin 2C receptors in the brain.
When the brain receptors are activated, a person tends to eat less and feel full after eating smaller amounts of food.
The current FDA approval was based on clinical data that confirmed bioequivalence of once-daily 20mg Belviq XR with twice-daily 10mg BELVIQ tablets, thereby increasing the convenience of administration when compared to a twice-daily 10mg tablet.
The approval for BELVIQ XR will help Eisai continue its work to address unmet medical needs within the clinical management of obesity, thereby increasing the benefits obtained by the patients and their families.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataThe FDA approval has been obtained by Arena Pharmaceuticals, with whom Eisai and its US subsidiary have signed an exclusive licensing agreement to market lorcaserin hydrochloride.
In June 2012, lorcaserin hydrochloride was approved by the US FDA in combination with a reduced-calorie diet and increased physical activity for chronic weight management in adult patients.
The drug was launched in the US under the brand name Belviq in July 2013.
