BEIJING, Dec. 29(Xinhuanet) -- US drug maker Celgene Corp announced Tuesday that the Food and Drug Administration has approved Revlimid, a new drug for the treatment of patients with myelodysplastic syndromes (MDS).
Revlimid treats a type of MDS involving a certain genetic abnormality. MDS can develop following treatment with drugs or radiation therapy for other diseases, or it can develop without any known cause. Patients with MDS may need blood and platelet transfusions and antibiotic therapy for infections.
In clinical trials, patients treated with Revlimid no longer needed transfusions, with most patients becoming independent of transfusion by three months, said the FDA. The transfusion-free period lasted for an average of 44 weeks.
Revlimid structurally resembles another drug, Thalomid, which is known to cause severe birth defects.Like Thalomid£¬Revlimid will get a "black box" warning about preventing fetuses from being exposed to Revlimid.
Celgene is marketing Revlimid under a risk-management plan called RevAssist, which is designed to prevent fetal exposure to Revlimid. Only doctors and pharmacists registered with the program will prescribe or dispense Revlimid.
An estimated 7,000 to 12,000 new cases of MDS are diagnosed yearly in the United States, generally in patients 60 or older. Typical symptoms include weakness, fatigue, infections, easy bruising, bleeding, and fever.
(Agencies)
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