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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.
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