Aug 5 2010
Lux Biosciences, Inc. today announced that the U.S. Food and Drug Administration's Center of Drug Evaluation and Research has issued a Complete Response letter regarding the New Drug Application (NDA) for Luveniq™ (oral voclosporin) for the treatment of non-infectious uveitis.
“We continue to work with FDA to address their outstanding questions regarding the safety and efficacy of Luveniq™, and the Lux Biosciences' board of directors is supportive of our starting the additional trial”
FDA issues a Complete Response letter when the review of a file is completed and questions remain that preclude the approval of the NDA in its current form. Lux Biosciences and its partner Isotechnika Pharma are evaluating the Complete Response letter, in which the FDA has indicated that it regards the data from one of the two pivotal studies submitted in the NDA as positive. Lux Biosciences plans to conduct an additional pivotal trial of Luveniq, expected to begin before the end of 2010.
"We continue to work with FDA to address their outstanding questions regarding the safety and efficacy of Luveniq™, and the Lux Biosciences' board of directors is supportive of our starting the additional trial," said Dean Mitchell, Lux Biosciences' President and Chief Executive Officer. "At the same time, the European Medicines Agency review of the Marketing Authorization Application for Luveniq remains on course for completion in the first quarter of 2011."
Lux Biosciences announced submission of both the NDA and MAA for Luveniq on February 3, 2010.
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