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news.An EMEA committee has adopted a positive opinion on orphan medicinal product designation for Lux Biosciences' investigational therapeutic for the treatment of chronic, non-infectious uveitis.
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The drug, LX211, is a next-generation calcineurin inhibitor intended for the treatment of non-infectious posterior, intermediate and panuveitis (an autoimmune disease characterized by chronic inflammation of the eye).
The EMEA will now forward the opinion to the European Commission. The decision will be adopted by the Commission, within 30 days of its receipt of the opinion. Orphan drug designation provides a variety of incentives, including market exclusivity for up to 10 years following approval, fee reductions and free scientific advice.
Lux Biosciences was previously granted orphan drug status for LX211 by the FDA in the US.
Lux Biosciences began enrolling patients in pivotal clinical trials for LX211 earlier this year. The company is conducting three controlled, double-masked studies aimed at supporting the approval of that product as a treatment for uveitis, collectively designated the LUMINATE program. The LUMINATE program represents the largest and most comprehensive clinical program ever undertaken in the field of uveitis.