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Clavis Pharma Receives US Orphan Drug Designation for ELACYT(TM)

26 Jun 2008 - Clavis Pharma announced that the US Food & Drug Administration (FDA) has granted orphan drug designation to ELACYT(TM) for the treatment of Acute Myeloid Leukaemia (AML). Within haematology, Clavis Pharma is currently conducting a Phase II study with ELACYT in patients undergoing second salvage therapy for AML, and a Phase I study with ELACYT in combination with idarubicin, in patients undergoing first salvage treatment (patients with refractory /relapsed AML).
 
"We are pleased to receive this orphan drug designation for ELACYT, in addition to the European Commission designation received last year" says Geir Christian Melen, CEO of Clavis Pharma. "Patients with AML need better agents as current treatment options are highly unsatisfactory. This designation is an important milestone in Clavis Pharma's strategy to achieve marketing approval for ELACYT as swiftly as possible."