Celgene International Sàrl (CELG) said the European Medicines Agency's or EMA: Committee for Medicinal Products for Human Use or CHMP has adopted a positive opinion for REVLIMID to treat patients with transfusion-dependent anemia due to low or intermediate-1-risk myelodysplastic syndromes or MDS associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.
The CHMP, that reviews applications for all 27 member states in the European Union or EU, as well as Norway and Iceland, has recommended approval for REVLIMID in this indication. The European Commission, which generally follows the recommendation of the CHMP, is believed to make its final decision within two to three months.
MDS is a type of cancer where the production of blood cells and platelets by the bone marrow is disrupted, which can often lead to severe anemia, infections and bleeding.
The CHMP positive opinion was based on the results of MDS-004, a phase III, multi-center, randomized, double-blind, placebo-controlled trial. The largest trial of MDS del(5q) patients conducted to-date, MDS-004 compared the efficacy and safety of once-daily oral treatment with REVLIMID to placebo in 205 patients at 37 participating centers throughout Europe.
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