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.
“LX211 at the recommended dose of 0.4 mg/kg twice daily, possesses a
favorable benefit-risk profile for the treatment of noninfectious
uveitis involving the intermediate or posterior segments of the eye”
“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.”
Results from the LUMINATE program, submitted in support of both the U.S.
and European marketing applications, showed that LX211 at the
recommended dose of 0.4 mg/kg twice daily provided clinically meaningful
efficacy and enabled preservation of vision in treated patients, a
critical patient benefit. Study LX211-01, in subjects with uncontrolled
uveitis, showed LX211 to rapidly reduce inflammation in subjects with
moderately severe disease, either alone or in combination with systemic
corticosteroids. Subjects receiving LX211 experienced a 50% reduction in
mean vitreous haze as compared to 29% in placebo-treated subjects. The
proportion of subjects demonstrating an improvement of at least 2 grades
in vitreous haze or a grade of ≤1+ for the study eye at last visit was
64% in the LX211 group as compared to 46% in the placebo group.
Moreover, treatment with LX211 permitted the withdrawal of
immunosuppressive therapy and the use of 5 mg/day or less of prednisone.