FDA Issues Orphan Drug Status for Santen Sirolimus Drug
The FDA has granted orphan drug designation to the Japanese pharmaceutical company's sirolimus drug.
The US FDA has granted orphan drug status to Santen's sirolimus (DE-109, rapamycin) drug, a treatment for chronic / refractory anterior non-infectious uveitis, non-infectious intermediate uveitis, non-infectious panuveitis and non-infectious uveitis affecting the posterior segment of the eye.
The move follows the approval of orphan drug status by the European Commission in September 2011.
Sirolimus, an immunosuppressive and anti-proliferative agent, is being evaluated in a study assessing double-masked uveitis treatment (SAKURA) Phase III study to demonstrate the safety and efficacy of different doses of sirolimus in non-infectious posterior uveitis.
The orphan drug designation programme is intended to advance the inve
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