JERSEY CITY, N.J.--(BUSINESS WIRE)--Lux Biosciences today announced that the Pediatric Committee of the European Medicines Agency (EMEA) has issued a positive opinion on Lux’s Pediatric Investigation Plan (PIP) for LUVENIQ™ (oral formulation of voclosporin), the company’s potential first-in-class product in Phase 3 development for sight-threatening non-infectious uveitis. The PIP covers children and young adults between the ages of 2 and 17 years who are affected with uveitis. An accepted PIP is a pre-requisite for European approval of new drugs according to legislation passed in January 2007. The aim of the legislation is to facilitate the development of new medicines for children without subjecting them to unnecessary clinical trials or delaying the authorization of those medicines for use in adults.
