Arena, Eisai deal

The companies said Arena transferred the NDA for weight loss drug Belviq lorcaserin to Eisai. The deal establishes the pharma as the marketing authorization holder responsible for U.S. regulatory activities related to the commercialization of Belviq, including pharmacovigilance requirements. Eisai has marketing rights to lorcaserin in North America and most of South America, including Brazil under an amended 2010 deal (see BioCentury, July 5, 2010 & May 14, 2012).

In June, FDA approved the NDA for Belviq for chronic weight management. The serotonin (5-HT2C) receptor agonist is approved for use in adults with a BMI of 30 kg/m 2 or greater, or adults with a BMI of 27 kg/m 2 or greater who have at least one weight-related condition. The partners are required to conduct six postmarketing studies, including a long-term cardiovascular outcomes trial and five clinical trials in obese pediatric patients (see BioCentury, July 2). ...