Shire submits European marketing application for Gaucher disease drug

Shire has submitted an application to the European Medicines Agency for velaglucerase alfa – its enzyme replacement therapy for the treatment of Type 1 Gaucher disease.

The application follows the positive results of three phase III trials.

Shire’s request for an accelerated assessment of the velaglucerase alfa application has been accepted.

This is the third marketing application for the drug that has been submitted, with previous submissions having been made in the United States and Canada.

Timothy Cox, founder of the National Centre for the Treatment of Gaucher disease at Addenbrooke’s Hospital, stated: “Shire’s partnership with health regulators and physicians to devise and implement expanded access programs for velaglucerase alfa is greatly appreciated by treating physicians and the Gaucher community at large.”

In other Shire news, the firm announced last week that its attention-deficit/hyperactivity disorder treatment intuniv (guanfacine) produced no unique adverse affects in a recent clinical trial.