Lux Biosciences, Inc. today announced its submission of simultaneous regulatory filings to both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) seeking marketing approval for its investigational drug LUVENIQ(TM) (LX211; oral voclosporin) for the treatment of noninfectious uveitis involving the intermediate or posterior segments of the eye. Efficacy of LX211 in support of the indication sought was demonstrated in two controlled, randomized, multi-center trials including data from 450 patients at 56 sites in 7 countries. The safety data include a total of 2,110 subjects who received voclosporin during its clinical development in uveitis and psoriasis, about 500 of whom were treated for >36 weeks and about 200 for >52 weeks. LX211 had previously received orphan drug status from FDA and EMA, and fast track status from FDA. Based on the latter, Lux Biosciences has requested priority review from FDA. "The results seen in the LUMINATE clinical trial program, the largest completed to date in non-infectious uveitis, support our belief that LX211 has the potential to significantly advance the treatment of this blinding disease," said Ulrich Grau, Ph.D., Lux Biosciences' President and Chief Executive Officer. "This is the first regulatory filing of voclosporin in any indication, in any country, which made this submission a complex task. It incorporates the research and development undertaken by our collaboration partner Isotechnika over more than a decade, and that of Lux Biosciences over the last 3 ½ years. Simultaneous filings of both a U.S. New Drug Application (NDA) and a European Marketing Authorization Application (MAA) for LX211 represent a major milestone for Lux Biosciences."
He added, "I wish to thank all of the Lux Biosciences employees, our partner Isotechnika, investigators, patients, contractors and advisors who contributed to the development program and made these on-time filings possible. I am not aware of a company of our small size having accomplished a submission of this magnitude for a new molecular entity simultaneously in the United States and Europe. It is a tribute to our networked approach to development, whereby a large team led and managed by a small core group was able to complete a major international drug development program in record time."