PDCO has good news for Lux Bio and others

The Pediatric Committee (PDCO) of the European Medicines Agency (EMEA) has issued a positive opinion on a Pediatric Investigation Plan for Luveniq (oral voclosporin), Lux Bioscience's treatment for children and young adults between the ages of two and 17 years with sight-threatening, non-infectious uveitis.

The privately-held biotechnology company focused on ophthalmic diseases completed patient enrollment in mid-2008 in its LUMINATE pivotal clinical trial program, which is investigating the use of LUVENIQ in adult patients with non-infectious uveitis. Results from the LUMINATE program, which consists of three randomized, placebo-controlled, double-masked studies that together enrolled a total of about 560 patients at 58 sites in seven countries, are expected in early 2009.

The PDCO also adopted positive opinions on PIPs for the following medicines: Fingolimod HCl, from Swiss drug major Novartis, in the therapeutic area of neurology; treprostinil, from the USA's United Therapeutics, in cardiovascular diseases; and Telaprevir, from Irish drugmaker Tibotec, in infectious diseases.