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news.Lux Biosciences, a privately held biotechnology company, has announced that the pediatric committee of the European Medicines Agency has issued a positive opinion on the company's pediatric investigation plan for Luveniq, the company's potential product in Phase III development for non-infectious uveitis.
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The pediatric investigation plan (PIP) covers children and young adults between the ages of two 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.
Lux Biosciences has 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. Data 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 first quarter of 2009.
Pending a positive outcome of the Luminate Phase III trials and subsequent approval by US and European regulatory agencies, Luveniq will provide the first steroid-sparing therapy for uveitis.