Drug Approved for Bone Marrow Disorders
Rare conditions could lead to leukemia
FRIDAY, May 21, 2004 (HealthDayNews) -- The U.S. Food and Drug Administration has granted special approval to a drug designed to treat a class of rare bone marrow disorders called Myelodysplastic Syndrome (MDS).
MDS, characterized by a lack of normal blood cell production, may develop following chemotherapy treatment, or it may occur without a known cause, the agency said in a statement. In some cases, the disease can progress to a form of blood cancer called acute myeloid leukemia (AML).
Pharmion Corp.'s Vidaza (azacitidine) was given what the agency calls orphan drug status -- normally applied to conditions that affect fewer than 200,000 people in the United States. The designation encourages drug makers to create medications for which there are relatively small markets by granting rights to exclusively market the drugs for a period of seven years.
An estimated 7,000 to 12,000 new cases of MDS are diagnosed each year in the United States, the agency said. Although it can occur at any age, the disease primarily affects people older than age 60. Symptoms include weakness, fatigue, infections, easy bruising, bleeding and fever. MDS patients often require blood transfusions and antibiotic therapy to treat infections.
For more information about MDS, visit the National Cancer Institute.