EMA approval sought for non-infectious uveitis drug

LUVENIQ (LX211; oral voclosporin) has been filed for approval by the European Medicines Agency (EMA) and the US's Food and Drug Administration by Lux Biosciences. The drug is aimed at treatment of non-infectious uveitis for the intermediate or posterior segments of the eye.

“The results seen in the LUMINATE clinical trial programme, 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 and a half years. Simultaneous filings of both a US New Drug Application (NDA) and a European Marketing Authorization Application (MAA) for LX211 represent a major milestone for Lux Biosciences.”

Support of the indication sought for LX211 was demonstrated in two controlled, randomized, multi-centre 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.