Revlimid Approved For Treatment Of Myelodysplastic Syndrome (MDS) by FDA

by Medindia Content Team on  December 29, 2005 at 6:40 PM Drug News   - G J E 4
Revlimid Approved For Treatment Of Myelodysplastic Syndrome (MDS) by FDA
A new drug treatment, Revlimid for treatment of myelodysplastic syndrome (MDS), a rare blood disorder has been approved by the Food and Drug Administration (FDA). The approval was announced by Celgene Corp, manufacturer of the drug.

The exact cause of MDS is not known. However, increased incidence of MDS has been noticed following radiotherapy or chemotherapy. Transfusion of blood and blood products (platelet) is the usual form of treatment. Anti-biotics may also be given to treat the associated infection.

Symptoms of MDS include fatigue, generalized weakness, susceptibility to infections, bleeding tendency and fever. The incidence of MDS is as high as 7000 to 12000 in the United States with a majority of the cases diagnosed in patients over 60 years.

The new drug has been approved by the FDA, owing to its improved performance in clinical trials. The need for a blood transfusion was eliminated in patients treated with Revlimid. Infact, following 3 months of therapy, a majority of the patients became independent of transfusions. This effect was observed for an average of 44 weeks.

The new drug closely resembles another drug, Thalomid, known to cause severe birth defects when administered to the pregnant mother. On account of this structural similarity, a 'black box' warning would be issued to prevent fetal exposure to Revlimid.

The drug would further be marketed under a strict adherence to a risk-management strategy, called RevAssist. According to the plan, only registered participants of the program (doctors and pharmacists) would be authorized to prescribe or market Revlimid. This is expected to reduce the probability of fetal exposure to the teratogenic drug.


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