FDA Dermatology and Ophthalmology Drugs Advisory Committee to review Lux Biosciences’ Luveniq NDA

May 12 2010

Lux Biosciences, Inc. today announced that the Dermatology and Ophthalmology Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) is scheduled to review its New Drug Application (NDA) for Luveniq™ (oral voclosporin) for the treatment of non-infectious uveitis involving the intermediate or posterior segments of the eye on June 28, 2010.

Lux Biosciences submitted its NDA on February 4, 2010 seeking approval to market Luveniq™ in the United States; on March 30, 2010, the FDA accepted the NDA filing for review and granted the NDA priority review. The target PDUFA date for the FDA to complete its review of the Luveniq™ NDA is August 3, 2010. The FDA is not bound by the Advisory Committee's recommendation, but may take its advice into consideration when evaluating the NDA for Luveniq™.