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Lux Biosciences Inc. has submitted simultaneous regulatory filings to the FDA and the European Medicines Agency seeking marketing approval for an investigational drug, oral voclosporin (LUVENIQ or LX211), for the treatment of noninfectious uveitis involving the intermediate or posterior segments of the eye.
Jersey City, NJ
-Lux Biosciences Inc. has submitted simultaneous regulatory filings to the FDA and the European Medicines Agency (EMA) seeking marketing approval for an investigational drug, oral voclosporin (LUVENIQ or LX211), for the treatment of noninfectious uveitis involving the intermediate or posterior segments of the eye.
The drug previously had received orphan drug status from both agencies and fast-track status from FDA. Based on the latter, Lux Biosciences has requested priority review from FDA.
“This is the first regulatory filing of voclosporin in any indication, in any country, which made this submission a complex task,” said Ulrich Grau, PhD, Lux Biosciences’ president and chief executive officer.
Efficacy of the drug in support of the indication sought was demonstrated in two controlled, randomized, multicenter trials including data from 450 patients at 56 sites in seven countries, according to the company. The safety data include 2,110 subjects who received voclosporin during its clinical development for uveitis and psoriasis, about 500 of whom were treated for more than 36 weeks and about 200 for more than 52 weeks.
In one study in patients with uncontrolled uveitis, the drug-either alone or in combination with systemic corticosteroids-rapidly reduced inflammation in subjects with moderately severe disease, according to the company.
The second study demonstrated the efficacy of oral voclosporin in patients whose disease was clinically quiescent at the time of enrollment. Also in the second study, treatment with oral voclosporin enabled the concomitant withdrawal of immunosuppressive therapy and allowed the reduction of systemic corticosteroids to 5 mg/day or less, as well as the complete elimination of topical corticosteroid therapy.
“The results . . . support our belief that [the drug] has the potential to advance significantly the treatment of this blinding disease,” Dr. Grau said.
The recommended dose of the drug is 0.4 mg/kg twice daily.