June 25, 2008-Clavis Pharma today 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."
The US Orphan Drug Act provides incentives to encourage the development of drugs for rare disease conditions affecting fewer than 200,000 persons in the United States of America (USA). The designation allows for amongst others a possible exemption from the FDA-user fee and assistance in clinical trial protocol design. If ELACYT receives marketing approval for AML in the USA, the designation will entitle Clavis Pharma to exclusive marketing rights for AML for seven years following the approval.
It should be noted that orphan drug designation does not limit a drug to less common diseases. The drug may as well, in parallel or afterwards, be developed for more common diseases.
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