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news.Cyclacel Pharmaceuticals has announced that the European Medicines Evaluation Agency has designated sapacitabine as an orphan medicine in two separate indications: acute myeloid leukemia and myelodysplastic syndromes.
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Specifically the European Medicines Evaluation Agency’s (EMEA) Committee for Orphan Medicinal Products adopted a positive opinion on the company’s application to designate sapacitabine as an orphan medicinal product for the indications of acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS).
The objective of European orphan medicines legislation is to stimulate research and development of medicinal products for rare diseases by providing incentives to industry. An orphan designation in the EU confers a range of benefits to sponsor companies including market exclusivity for a period of 10 years, EMEA scientific advice on protocol development, direct access to the centralized procedure for review of marketing authorizations, EMEA fee reductions and eligibility for grant support from European agencies.
Cyclacel is currently enrolling patients in an open-label, US multicenter, randomized Phase II trial of oral sapacitabine in elderly patients with AML who are previously untreated or in first relapse.