Lux Biosciences, Inc. today announced that the European Medicines Agency (EMA) has accepted the filing of the company’s Marketing Authorization Application (MAA) for the company’s lead product, Luveniq™ (LX211; oral voclosporin) for the treatment of noninfectious uveitis involving the intermediate or posterior segments of the eye. Lux previously announced the filing of both the MAA and U.S. New Drug Application (NDA) for LX211, which has received Orphan Drug designation in both regions, on February 4, 2010.
“We are very pleased that our European marketing application for LX211 has been formally accepted for review”
“We are very pleased that our European marketing application for LX211 has been formally accepted for review,” said Eddy Anglade, M.D., Lux Biosciences’ Chief Medical Officer. “We now look forward to hearing from the U.S. Food and Drug Administration on our NDA filing, for which we have also requested priority review.”
The US FDA has up to 60 days to formally accept the completed application. Upon acceptance, the FDA will determine if the application will be granted priority review, which would allow for a six month review of the NDA.