Lux Biosciences Files for LUVENIQ(TM) Approval in US and Europe for Noninfectious Uveitis
2/4/2010 10:44:45 AM
JERSEY CITY, N.J.--(BUSINESS WIRE)--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™ (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.