On 28 October 2005, orphan designation (EU/3/05/324) was granted by the European Commission to ACE Pharmaceuticals BV, The Netherlands, for levamisole hydrochloride for the treatment of nephrotic syndrome.
Levamisole is recommended for use in high-dose steroid-dependent nephrotic syndrome in children, as adjuvant therapy following relapse on corticosteroids such as prednisone; or as an alternative to the use of an alkylating agent or cyclosporin.
In these patients, Levamisole has been shown to induce a significant number of complete remissions, reduce the steroid requirements necessary to induce such a remission, and decrease the incidence of relapse of the disease.
