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Launch of Zavesca®
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THE ACTELION ANNUAL REPORT 2002 |
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Launch of Zavesca®
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The worldwide marketing, distribution and monitoring capabilities that Actelion has created are attracting new business opportunities. In 2002, the company obtained a license to develop the exciting commercial potential of Zavesca® (miglustat), a small molecule oral therapy developed by Oxford GlycoSciences Plc (OGS) for the treatment of type 1 Gaucher’s disease. This rare lipid-storage disorder causes an enlargement of spleen and liver, bone disease and anemia. Before oral Zavesca®, the only existing etiologic treatment for this debilitating disease was an intravenous enzyme replacement therapy, which is unsuitable for some patients.
In November 2002, the European Commission granted marketing authorization for Zavesca®. Actelion started the market introduction in the European Union, beginning with the UK on March 3rd 2003. In the US, OGS received a non-approval letter from the Food and Drug Administration (FDA) earlier in 2002. In subsequent discussions between OGS, Actelion and the FDA, the companies intend to submit an amendment to the original New Drug Application (NDA) for Zavesca® in Q1 2003.
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