Shire seeks approval to treat Fabry disease
December 22, 2009 11:26 AM
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British drugmaker Shire plc today said it has submitted a biologic license application to the Food and Drug Administration for Replagal, its treatment for the rare enzyme deficiency Fabry disease.
If approved by the FDA next year, Replagal, currently available to Fabry disease patients in the United States under an FDA-approved treatment protocol, would compete with Fabrazyme, a drug produced by Cambridge-based biotechnology company Genzyme Corp.
Shire, which operates its human genetic therapies division out of Lexington, worked with the FDA to set up an early access program for Replagal earlier this year in response to Fabrazyme shortages.
The shortages have been caused by the temporary shutdown last summer of Genzyme's Allston Landing manufacturing plant, where the company discovered a virus in a bioreactor in June.
Replagal already is approved for use in 45 countries. Shire has also applied for FDA approval of another drug, velaglucerase alfa, that would compete with Cerezyme, the Genzyme treatment for Gaucher disease, another enzyme deficiency disorder.
(By Robert Weisman, Globe staff)
If approved by the FDA next year, Replagal, currently available to Fabry disease patients in the United States under an FDA-approved treatment protocol, would compete with Fabrazyme, a drug produced by Cambridge-based biotechnology company Genzyme Corp.
Shire, which operates its human genetic therapies division out of Lexington, worked with the FDA to set up an early access program for Replagal earlier this year in response to Fabrazyme shortages.
The shortages have been caused by the temporary shutdown last summer of Genzyme's Allston Landing manufacturing plant, where the company discovered a virus in a bioreactor in June.
Replagal already is approved for use in 45 countries. Shire has also applied for FDA approval of another drug, velaglucerase alfa, that would compete with Cerezyme, the Genzyme treatment for Gaucher disease, another enzyme deficiency disorder.
(By Robert Weisman, Globe staff)
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