Research & Development
US FDA accepts Biologics License Application for Horizon Therapeutics' Teprotumumab
11 September 2019 -

The United States Food and Drug Administration(FDA) has accepted the Biologics License Application for Ireland-based Horizon Therapeutics plc's (Nasdaq: HZNP) Teprotumumab, an investigational medicine intended for the treatment of active thyroid eye disease (TED), and granted it Priority Review designation, it was reported yesterday.

The US FDA grants Priority Review designation to applications for medicines that have the potential to provide significant improvements in the treatment of serious conditions. Priority Review is associated with an accelerated six-month review period compared to the standard ten-month review period. If approved, the product is to be the first US FDA-approved medicine for the treatment of active TED.

Timothy Walbert, chairman, president and chief executive officer, Horizon, said, 'Priority Review for the teprotumumab BLA is another positive step toward our goal to make a difference in the lives of people who are living with active TED – a painful, debilitating and vision-threatening rare disease. The accelerated review timeline is particularly important given that there is no FDA-approved medical treatment for TED and the window of time for treatment is limited before patients experience potentially long-term, permanent damage to their eyes.'



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