Shire has been boosted by the news that regulators in the USA will give a quicker review to the firm’s Fabry disease drug Replagal.

The company has received fast-track designation from the US Food and Drug Admininstration for Replagal (agalsidase alfa), its enzyme replacement therapy for Fabry disease. The drug has also been available under an early access programme in the USA since December following the temporary shutdown of a Genzyme manufacturing plant which caused the shortage of the latter’s Fabrazyme (agalsidase beta).

Shire actually recently withdrew its Biologics License Application for Replagal when the FDA requested additional human pharmacokinetic data to confirm comparability between product manufactured in roller bottles and that manufactured in bioreactors. The treatment has been on the market in Europe since 2001 and is produced there using the bioreactor process.

Following a suggestion from the FDA, Shire requested, and has now received, fast track status and will now initiate a rolling submission of the Replagal BLA and deliver the requested pharmacokinetic data around mid-year. The mechanism enables the agency to commence its review and proceed on a rolling basis as additional sections are completed and submitted.

Shire is also hoping to get approval from the US Food and Drug Administration for its Gaucher disease therapy velaglucerase alfa, to be marketed as Vpriv, by the end of the month.