Arena Pharmaceuticals Inc. and partner Eisai Inc. sent a package off to FDA Dec. 27 that they believe satisfies the agency’s concerns on a range of issues related to their novel weight loss drug lorcaserin, including apparently exhaustive studies on the pathogenesis of rat mammary tumors that may be published separately.
Arena Ready For FDA To Reconsider Weight-Loss Drug Lorcaserin
Arena and Eisai expect to hear in the next week or so whether FDA will accept their answer to an October 2010 “complete response” letter and set a new action date for their novel weight loss drug.