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news.Celgene International Sàrl, the Swiss wholly-owned subsidiary of New Jersey-based Celgene Corporation, has been issued with a Final Appraisal Determination (FAD) recommending the drug VIDAZA within its licensed indication from the National Institute for Health and Clinical Excellence (NICE) as an option to treat myelodysplastic syndromes (MDS) and acute myeloid leukaemia patients in England and Wales.
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NICE’s evaluation took into account peer-reviewed clinical studies that demonstrated VIDAZA as an innovative epigenetic, life-extending, cost-effective therapy for the National Health Service (NHS).
Celgene Corporation CEO Robert Hugin said the positive FAD would help in widespread access to a therapy with documented prolonged survival rates in incurable blood cancers.
The FAD has been sent to the appraisal consultees who may appeal the decision within 15 days, failing which, NICE may use the FAD as the basis of its final guidance to the NHS, expected in the first half of 2011.