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FDA makes Celgene wait on blood disorder drug

The US Food and Drug Administration has told Celgene that it needs more time to review Revlimid, the US biotech company's treatment for a serious blood disorder

The US Food and Drug Administration has told Celgene that it needs more time to review Revlimid, the US biotech company's treatment for a serious blood disorder.

Revlimid is a newer version of the infamous thalidomide, a drug that was used by pregnant women in the 1960s to combat morning sickness but was later banned worldwide after it was found to cause severe birth defects.

Last month, the FDA's oncologic drug advisory committee voted 10-5 in favour of recommending full approval of Celgene's Revlimid for patients with myelodysplastic syndromes (MDS), a disease in which bone marrow makes deformed or underdeveloped red blood cells.

The FDA has decided to extend the action date for its review of Revlimid's new drug application to January 7. Celgene said it had been informed that the extension was due to the FDA needing more time to review additional information on the company's risk-management programme ìRevAssistî.

The programme is designed to observe the drug's toxicity and the chances that it will cause birth defects. It also seeks to inform doctors on how to manage the possible risk of cytopenia, or the reduction of blood cells, in patients.

ìWe are working closely with the FDA to enable completion of their review as quickly as possible for Revlimid approval,î said Celgene chief operating officer Sol Barer.

He added that the company expects to submit a separate application in November to treat multiple myeloma, a blood cancer, in patients where previous treatment with other drugs failed.

Celgene spokesman Brian Gill said the company did not expect the FDA to wait for additional data on Revlimid for MDS patients, as certain FDA panel members had requested.

Thalidomide, also known by Celgene's brand name Thalomid is currently approved to treat leprosy but is more commonly used as an off-label treatment in patients with multiple myeloma, a blood cancer.

During last month's FDA-panel meeting, the agency said that while it had safety concerns with Revlimid, it believed the drug was safer than thalidomide.

30th September 2008

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