FDA accepts filing of Lux Biosciences' NDA for Luveniq and grants application priority review

Lux Biosciences, Inc. today announced that the U.S. Food and Drug Administration has accepted the filing of the company's New Drug Application for Luveniq™ (oral voclosporin) and has granted the application priority review.

“We are very pleased that Luveniq is now under active regulatory consideration in both the United States and Europe, and that the FDA is providing an expedited review in recognition of the potential of this experimental drug and high need for new therapies”

A Priority Review designation is given to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists. A Priority Review means that the time it takes FDA to review a new drug application is reduced; the goal for completing a Priority Review is six months.

"We are very pleased that Luveniq is now under active regulatory consideration in both the United States and Europe, and that the FDA is providing an expedited review in recognition of the potential of this experimental drug and high need for new therapies," said Eddy Anglade, M.D., Lux Biosciences' Chief Medical Officer.