February 04, 2010
NDA submitted for Luveniq for noninfectious uveitisLux Biosciences announced that a New Drug Application (NDA) has been submitted to the FDA seeking approval of Luveniq (LX211, voclosporin capsules) for the treatment of noninfectious uveitis involving the intermediate or posterior segments of the eye. This submission includes efficacy results from two controlled, randomized, multi-center trials including data from 450 patients at 56 sites in 7 countries. Also included is safety data from a total of 2,110 subjects who received voclosporin during its clinical development in uveitis and psoriasis, of which, approximately 500 of whom were treated for >36 weeks and about 200 for >52 weeks.
Luveniq is the oral form of a next-generation calcineurin inhibitor, voclosporin. Compounds of this class of molecules reversibly inhibit immunocompetent lymphocytes, particularly T-lymphocytes, as well as inhibiting lymphokine production and release.
For more information call (201) 946-0551 or visit www.luxbio.com.