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Biopharmaceutical company, Shire plc announces it has received fast track designation from the FDA for Replagal (agalsidase alfa).
In December 2009 Shire filed a BLA for Replagal. The FDA requested additional human pharmacokinetic data to verify comparability between the product that was manufactured in roller bottles, and that which is manufactured in bioreactors. Product made by the bioreactor process is already approved for commercial use in the European Union as well as a number of other countries.
Consequently, Shire withdrew its December BLA filing, and, at the suggestion of the FDA, requested and received Fast Track designation. With immediate effect Shire will initiate the rolling submission of the Replagal BLA, and will submit the requested pharmacokinetic data around mid-year.
“We will continue to work closely with the FDA in the coming months on the rolling BLA submission for Replagal,” said Sylvie Gregoire, President, Shire Human Genetic Therapies.
“We remain committed to continuing to provide Fabry patients in the United States with Replagal under the treatment protocol.”
Replagal is to be recommended for the treatment of Fabry disease in 45 countries and has been available to US patients since December 2009 under an FDA-approved treatment protocol filed at the request of FDA.
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