Regulatory Focus™ > News Articles > Shire Pulls BLA Submission After FDA Demands More Clinical Trials

Shire Pulls BLA Submission After FDA Demands More Clinical Trials

Posted 16 March 2012 | By

Biopharmaceutical manufacturer Shire withdrew its Biologics License Application (BLA) for Fabry drug Replagal (agalsidase alfa) after the US Food and Drug Administration (FDA) indicated that the company needed to conduct more clinical trials.

Ireland-based Shire's withdrawal of its application on 15 March was reportedly due to the perception that FDA's demands would create a "significant delay" that would push back any possible approval of the product by years.

FDA has encouraged Shire to submit the BLA for Replagal both in 2009 and 2011, making the demands all the more frustrating for Shire.

A Shire spokeswoman said in a statement that the company is "extremely disappointed that we feel compelled to make this decision."


Read more:

Pharma Times - Shire withdraws Replagal in USA as FDA wants more trials

PMLive - Shire pulls Replagal submission in US after clinical trial demand


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