Orphan Drug Status for Sirolimus for Non-Infectious Uveitis
Santen announced that the FDA has granted orphan drug designation for sirolimus (DE-109) for the treatment of chronic/refractory anterior non-infectious uveitis, non-infectious intermediate uveitis, non-infectious panuveitis, and non-infectious uveitis affecting the posterior segment of the eye. As sirolimus is currently being evaluated in a Phase 3 clinical trial, Santen Inc. does not make any safety or efficacy claims about sirolimus as a treatment for uveitis.
Sirolimus is the active pharmaceutical ingredient in Rapamune (Pfizer), an immunosuppressive agent used in renal transplant patients. It is a broad-acting compound that is known to be an immunosuppressive and anti-proliferative agent.
For more information call (415) 268-9100 or visit www.santeninc.com.