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.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
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.
