The FDA has granted fast track designation to LX211, a next generation calcineurin inhibitor developed by Lux Biosciences.
The FDA has granted fast track designation to LX211, a next generation calcineurin inhibitor developed by Lux Biosciences.
LX211 is intended for the treatment of non-infectious posterior, intermediate and panuveitis. The fast track designation means that various new means to expedite the development of the drug can now be explored. For example, the company will be allowed to submit portions of the New Drug Application (NDA) for early review as part of a "rolling" submission.
Lux is currently conducting three controlled, double-masked studies aimed at supporting the approval of LX211 as a treatment for uveitis, collectively called the LUMINATE programme. Enrolment is expected to be completed by early 2008 and, if successful, Lux hopes to seek approval later that year.
