Belviq breaks through
Next steps in obesity after FDA approval of Belviq lorcaserin from Arena, Eisai
Arena Pharmaceuticals Inc. and partner Eisai Pharmaceuticals Co. Ltd. will have a fine line to walk as they market Belviq lorcaserin for obesity. They want to improve patient compliance, which historically has not been good in obesity, while also preventing the key thing doctors believe could make Belviq a blockbuster - combining it with the generic drug phentermine.
On June 27, FDA approved Belviq in combination with diet and exercise for chronic weight management in adults with a BMI >=30 kg/m2 or in adult patients with a BMI >=27 kg/m2 with at least one co-morbid indication.
While Belviq's label limits its use to monotherapy, most doctors contacted by BioCentury believe the drug will see its largest use in combination with phentermine and possibly other drugs, including GLP-1 analogs.
Marketing issues aside, early stage companies contacted by BioCentury believe the Belviq approval could signal a resurgence in obesity drug development, albeit for next-generation developers focused on novel targets.
Long last mile
The approval of Belviq was more than two years in the making.
Arena submitted an NDA in December 2009. The following year, the biotech received two pieces of bad news - a negative panel vote and a complete response letter requesting additional preclinical studies and data readjudication to rule out a cancer signal (see BioCentury, Sept.20, 2010).
Over the next 14 months, Arena conducted the studies and analysis requested by the agency, submitting its response this past January.
In May, FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 18-4 with one abstention that the benefit-risk profile for Belviq supported approval. The panel was reassured after the readjudicated data and additional preclinical studies showed a lower risk of tumors than previously believed (see BioCentury, May 14).
The panel did suggest FDA require a REMS for Belviq as part of Arena's post-marketing commitments to address the potential for heart valve problems.
Belviq is a serotonin (5-HT2C) receptor agonist. Two nonspecific serotonin receptor agonists, fenfluramine and dexfenfluramine, were pulled from the U.S.