Shire has submitted a marketing application to the European Medicines Agency for velaglucerase alfa, a new enzyme replacement therapy to treat type 1 Gaucher disease.
The company's application for accelerated assessment was accepted based on the global supply shortage of approved treatments as well as positive results from three velaglucerase alfa Phase III trials.
National Centre for the Treatment of Gaucher disease professor of medicine Timothy Cox said that Gaucher disease is a debilitating condition and the continuing imiglucerase supply shortage has had a significant impact on patients.
"We welcome the news of the submission of the velaglucerase alfa MAA in Europe," he said.
This is the third marketing application for velaglucerase alfa, following previous submissions in the US and Canada.