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Shire bids for Gaucher approval


The US Food and Drug Administration (FDA) is considering for possible approval a Shire treatment for Gaucher disease that is being mooted as an alternative to the Genzyme drug Cerezyme.

Meanwhile, the company has received a treatment protocol that allows it to make the drug available to sufferers of type 1 Gaucher disease before being approved by the FDA.

Submission to the FDA had been originally planned for next year, but has been brought forward because of a shortage of Cerezyme due to a virus at Genzyme’s Allston manufacturing plant.

Because of the shortage of Cerezyme, adults suffering from the disease are excluded from receiving it except in rare circumstances of acute illness.

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Said Sylvie Gregoire, president of Shire Human Genetic Therapies: “The submission of the new drug application for velaglucerase alfa, earlier than previously announced, is an important milestone for Shire, bringing us another step closer to providing a new treatment option for patients with Type 1 Gaucher disease.”

Gregoire said Shire is on track to submit the drug to European regulators by the end of 2009.

Copyright Press Association 2009

Please note: This story has been corrected from 23/11/2009

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