BOUDRY, Switzerland – (BUSINESS WIRE) – Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation (Nasdaq:CELG) today announced that the National Institute for Health and Clinical Excellence (NICE) has issued a Final Appraisal Determination (FAD) recommending Vidaza® within its licensed indication, as an option for the treatment of patients in England and Wales with myelodysplastic syndromes (MDS) and acute myeloid leukaemia.
NICE determined that Vidaza, as an innovative, life-extending therapy, is a cost-effective use of NHS resources.
“We applaud the positive FAD from NICE that will provide patients more widespread access to a therapy that has been shown to prolong survival in these incurable blood cancers,” said Robert J. Hugin, Chief Executive Officer of Celgene Corporation.
The FAD issued today has been sent to the appraisal consultees who may appeal the decision within 15 days.
If there is no appeal, NICE may use the FAD to form the basis of its final guidance to the NHS, expected in the first half of 2011.
NICE’s evaluation considered peer-reviewed clinical studies that demonstrated Vidaza extended the lives of patients with MDS by more than nine months compared to conventional care regimens.