Uveitis drug earns EU orphan status

September 14, 2011

The European Commission (EC) has granted orphan drug status for an immunosuppressant drug (Sirolimus, Santen Inc.) for the treatment of chronic non?infectious uveitis. The designation follows a positive opinion from the Committee for Orphan Medicinal Products within the European Medicines Agency in June.

Emeryville, CA-The European Commission (EC) has granted orphan drug status for an immunosuppressant drug (Sirolimus, Santen Inc.) for the treatment of chronic non‐infectious uveitis. The designation follows a positive opinion from the Committee for Orphan Medicinal Products within the European Medicines Agency in June.

Santen Inc. is the U.S. subsidiary of global ophthalmic pharmaceutical company Santen Pharmaceutical Co. Ltd., Osaka, Japan.

Sirolimus, which was originally known as rapamycin, is used to prevent rejection in organ transplantation.

Orphan drug designation by the EC is granted to medicines intended for treatment of life-threatening or chronically debilitating pathologies that affect no more than 5 in 10,000 people in the European Union (EU).

An orphan designation in the EU confers a range of benefits to sponsor companies, including scientific advice on all aspects of product development at a reduced fee, direct access to the centralized procedure for marketing authorization, and eligibility for certain financial incentives made available by the EC and its member states to support research into and development of orphan drugs. If the product is approved for marketing, the designation also provides 10 years of marketing exclusivity subsequent to product approval if the orphan designation still prevails at the time of marketing authorization.

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