FDA panel supports approval of Arena's lorcaserin for weight management; Arena, Eisai expand agreement for drug
Thursday, May 10 2012 | Comments
and Arena Pharmaceuticals Inc.
reported that a Food and Drug Administration
advisory panel recommended that Arena's lorcaserin hydrochloride be approved as a weight-loss treatment.
The firms said the FDA's Endocrinologic and Metabolic Drugs Advisory Committee
voted 18-4, with one abstention, that--based on available data--lorcaserin's benefits outweigh its risks when used long term in a population of overweight and obese individuals.
Lorcaserin is intended for weight management, including weight loss and maintenance of weight loss, in patients who are obese or in patients who are overweight and have at least one weight-related comorbid condition.
In January, the FDA assigned a Prescription Drug User Fee Act target date of June 27 for the lorcaserin New Drug Application (NDA). Arena submitted the original NDA for lorcaserin in December 2009, but the FDA issued a complete response letter regarding the NDA in October 2010. Arena submitted its response to the FDA's letter in December.
Arena's wholly owned subsidiary, Arena Pharmaceuticals GmbH, granted Eisai exclusive rights to market and distribute lorcaserin in the United States if the drug is approved.
In separate news, Arena and Eisai expanded
their marketing and supply agreement for lorcaserin to encompass most of North and South America, including Canada, Mexico and Brazil.
As stated in the original agreement, Arena will manufacture lorcaserin at its facility in Switzerland and sell the finished product to Eisai for marketing and distribution. Under the expanded agreement, Arena will receive an up-front payment and is eligible to receive regulatory and development milestone payments, as well as increased payments based on net sales of the drug in Eisai's territories.