Santen Inc., the U.S. subsidiary of global ophthalmic pharmaceutical company Santen Pharmaceutical Co., Ltd. (Osaka, Japan), & Global Clinical Development and Medical Affairs at Santen today announced that the U.S. Food and Drug Administration (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. The designation follows the granting of orphan drug status by the European Commission in September 2011.
About Sirolimus:
Sirolimus was isolated in the 1970’s from Streptomyces hygroscopicus in soil samples from Easter Island. Sirolimus is the active pharmaceutical ingredient in two products approved by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), specifically, Rapamune®, an immunosuppressive agent used in renal transplant patients, and the CYPHER® Sirolimus-eluting Coronary Stent approved for improving coronary luminal diameter in patients with symptomatic ischemic disease.
Sirolimus was isolated in the 1970’s from Streptomyces hygroscopicus in soil samples from Easter Island. Sirolimus is the active pharmaceutical ingredient in two products approved by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), specifically, Rapamune®, an immunosuppressive agent used in renal transplant patients, and the CYPHER® Sirolimus-eluting Coronary Stent approved for improving coronary luminal diameter in patients with symptomatic ischemic disease.
Sirolimus, originally known as rapamycin, is a broad-acting compound that is known to be an immunosuppressive and anti-proliferative agent. It is currently being evaluated in a Phase III study entitled SAKURA (Study Assessing double-masKed Uveitis tReAtment), to assess the safety and efficacy of different doses of sirolimus in non-infectious posterior uveitis. (If you are an expert and want to know the clinical trial details, please click here.)
About Uveitis:
Uveitis is a group of intraocular inflammatory disorders with both infectious and autoimmune etiologies. Typically uveitis is classified by anatomic location in the uvea. Anterior uveitis is the most common type and can involve the cornea, iris, and/or ciliary body. Intermediate uveitis affects the middle portion of the eye, such as the ciliary body and vitreous. Posterior uveitis can involve the vitreous, choroid, retina, and/or optic nerve. Panuveitis, also referred to as diffuse, can encompass anterior, intermediate, and posterior segments.
Uveitis is a group of intraocular inflammatory disorders with both infectious and autoimmune etiologies. Typically uveitis is classified by anatomic location in the uvea. Anterior uveitis is the most common type and can involve the cornea, iris, and/or ciliary body. Intermediate uveitis affects the middle portion of the eye, such as the ciliary body and vitreous. Posterior uveitis can involve the vitreous, choroid, retina, and/or optic nerve. Panuveitis, also referred to as diffuse, can encompass anterior, intermediate, and posterior segments.
No comments:
Post a Comment