Shire plc (SHPGY,SHP.L) announced that it has withdrawn its Biologics License Application or BLA for Replagal (agalsidase alfa) with the US Food and Drug Administration.
Shire stated that it has been in ongoing dialogue with the FDA since the supply shortage of the only US approved treatment for Fabry disease.
Shire said that the recent interactions with the FDA have led the Company to believe that the agency will require additional controlled trials for approval. No concerns over the product's safety profile were raised by the FDA. Shire said it has concluded that the likely additional studies would cause a significant delay, and an approval of Replagal for US patients would only be possible in the distant future. Shire has therefore decided to withdraw its BLA.
Replagal has been approved in the European Union for over 10 years and is marketed in 46 countries around the world, treating over 70% of the Fabry patient population worldwide.
Shire said that it does not have any impact on the treatment of Replagal patients outside the US, and its 2012 financial guidance due to withdrawal of the BLA.
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