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Global speciality Biopharmaceutical company Shire has filed a treatment protocol for velaglucerase alfa in development for the treatment of Gaucher disease. Due to a potential restriction on the approved treatment of the disease the new treatment was developed at the request of the FDA.
Velaglucerase alfa is made with Shire’s proprietary technology, in a human cell line. The enzyme produced has the exact human amino acid sequence and carries a human glycosylation pattern.
If approved by the FDA, Shire would provide the treatment free of charge allowing physicians to treat patients with Gaucher disease and have a sufficient supply of velaglucerase alfa to meet patient demand. The company is now working with the FDA to file a New Drug Application (NDA) for velaglucerase alfa as early as possible in order to treat the genetic disease.