Recently, Bristol-Myers Squibb Co. (BMY: 25.17 -0.43 -1.68%) and partner Otsuka Pharmaceutical Co. Limited announced that the US Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) for leukemia drug Sprycel (dasatinib) and will review it on a priority basis.The companies are seeking marketing approval for the drug as a first-line therapy of adults newly diagnosed with chronic myeloid leukemia (CML). Bristol-Myers Squibb is partnered by Otsuka for commercializing the drug in the US, Japan and major European countries.
The US regulatory authority generally reviews those drugs on a priority basis, which offer major advances in treating diseases having no adequate therapy. Applications for priority review designated drugs are reviewed by the FDA within six months of submission as against the usual ten months. Based on that criterion, a response from the FDA should to be out in the third quarter of 2010 (projected target date: October 28, 2010).
Sprycel is available in the US markets since 2006 for treating adults in all stages of CML - chronic, accelerated, or myeloid or lymphoid blast phase- who failed to respond adequately to prior therapies including Novartis’ (NVS: 49.52 -0.03 -0.06%) Gleevec.
Last month, Bristol’s leukemia drug was found to be more effective than Gleevec in treating patients suffering from newly diagnosed chronic myeloid leukemia. Furthermore, the drug is also approved for treating adults suffering from Philadelphia chromosome acute lymphoblastic leukemia who have not responded to other treatments.
We believe that Sprycel’s approval for the indication will broaden the treatment opportunities for patients suffering from the disease and further boost Bristol’s top line. It is estimated that CML, which involves the production of an uncontrolled amount of abnormal white blood cells in the body, affects approximately 22,475 people in the US.
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