Pharmaceuticals firm Shire has withdrawn its Biologics Licence Application for its enzyme replacement product REPLAGAL with the US Food and Drug Administration (FDA).
Recent interactions with the FDA have led the Shire to believe that the agency will require additional controlled trials for approval of the product. No concerns over the product's safety profile were raised by the FDA. Shire 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.
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