Eisai Inc. and Arena Pharmaceuticals, Inc. ARNA -0.96% announced today that Arena has transferred the BELVIQ® (lorcaserin hydrochloride) New Drug Application (NDA) to Eisai. The transfer establishes Eisai as the marketing authorization holder responsible for regulatory activities in the United States related to the commercialization of BELVIQ, including pharmacovigilance requirements. Arena will continue in its oversight role for the global development of BELVIQ while working closely with Eisai for the joint development plan in the United States.
"The NDA transfer furthers our commitment to BELVIQ as we prepare to launch in the United States and submit applications for approval throughout the Americas," said Lonnel Coats, President and Chief Executive Officer, Eisai Inc.
Eisai plans to submit marketing authorization applications based on the NDA to the health authorities throughout the territories in North and South America for which it currently holds commercialization rights, including Mexico, Brazil and Canada.
"We look forward to further exploring the therapeutic potential of BELVIQ and supporting Eisai's efforts to obtain marketing approval in additional North and South American countries," said Jack Lief, Arena's President and Chief Executive Officer.
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