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news.The US FDA has granted orphan drug status for Santen's sirolimus (DE-109, rapamycin) to treat chronic/refractory anterior non-infectious uveitis, non-infectious intermediate uveitis, non-infectious panuveitis, and non-infectious uveitis affecting the posterior segment of the eye.
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Sirolimus, an immunosuppressive and anti-proliferative agent, is being assessed in 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 status has been granted by FDA following the approval of orphan drug status by the European Commission in September 2011.
The orphan drug designation programme is intended to advance the investigation and development of drugs that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions.