Shire’s Replagal application fast-tracked by FDA

Shire is to see its biologics licence application (BLA) for the Fabry disease drug Replagal fast-tracked by the Food and Drug Administration (FDA).

The regulator has identified the treatment as being one that services an unmet medical need and is therefore allowing Shire to file the sections of the BLA as they become available, rather than demanding they be submitted all at once.

As a result, Shire will be initiating this process immediately and expects to be able to submit the requested pharmacokinetic data in the middle of this year.

According to the pharmaceuticals firm, Replagal is currently the only human-cell-line-derived form of enzyme replacement therapy designated for long-term Fabry disease treatment.

Sylvie Gregoire, president at Shire Human Genetic Therapies, said: “We will continue to work closely with the FDA in the coming months on the rolling BLA submission for Replagal.”

Earlier this month, the healthcare firm published its financial results for 2009, during which the company maintained its revenue at the same level seen in 2008.