Shire’s Gaucher Therapy Fast Tracked by FDA

Shire, a biopharmaceutical company that focuses on specialty needs, recently announced that their Gaucher Disease therapy has been fast tracked by the United States Food and Drug Administration.

Gaucher Disease is a genetic disease in which the accumulation of fatty substances in certain organs and cells. Type I of Gaucher Disease, which is the type that this therapy is designed for, occurs in about one in every 50,000 live births. Symptoms include enlarged spleen, enlarged liver, bone disease and skeletal weakness.

Shire’s Gaucher Disease therapy is an enzyme replacement therapy called velaglucerase alfa. Currently, the biopharmaceutical company is in conducting a phase three clinical program that includes about 100 patients in a total of ten countries.

Due to the therapy gaining fast track status by the FDA, Shire is hopeful that their Gaucher Disease therapy will be available to a world market sooner rather than later.

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