Company seeks New Drug Application approval for Revlimid as a treatment for patients with myelodysplastic syndromes who are dependent on blood transfusions.Summit”s Celgene (Nasdaq: CELG) said Tuesday the U.S. Food and Drug Administration has formally accepted for review the company”s New Drug Application for Revlimid. The company is seeking approval for Revlimid as a treatment for patients with myelodysplastic syndromes (MDS) who are dependent on blood transfusion.
Celgene said it hopes to hear from the FDA in two weeks.
Revlimid is a member of a new class of novel immunomodulatory drugs, or IMiDs. Celgene is evaluating treatments with Revlimid for a broad range of hematology and oncology conditions, including multiple myeloma, chronic lymphocytic leukemia and solid-tumor cancers.
Myelodysplastic syndromes are a group of hematologic malignancies that affect approximately 300,000 people worldwide. The syndrome occurs when blood cells remain in an immature or “blast” stage within the bone marrow and never develop into mature cells capable of performing their necessary functions. Eventually, the bone marrow may be filled with blast cells suppressing normal cell development. According to the American Cancer Society, 10,000 to 20,000 new cases of MDS are diagnosed each year in the U.S.
At the close of trading, Celgene shares were down $0.23 to $39.75.