FDA grants orphan drug status to Santen Sirolimus drug - Clinical Trials Arena
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FDA grants orphan drug status to Santen Sirolimus drug

14 Nov 2011

The US Food and Drug Administration (FDA) has issued orphan drug status for Santen's sirolimus (DE-109, rapamycin) drug as 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 US Food and Drug Administration (FDA) has issued orphan drug status for Santen’s sirolimus (DE-109, rapamycin) drug as 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.

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 move follows 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.