Shire has filed its new Gaucher disease drug with regulators in Europe as it looks to fill the void created by the shortage of the only approved drug for the disease, Genzyme Corp’s Cerezyme.
The drugmaker has submitted a marketing authorisation application to the European Medicines Agency for velaglucerase alfa, an enzyme replacement therapy for type 1 Gaucher disease. The filing is similar to the one made in September to the US Food and Drug Administration in that the EMEA’s Committee for Medicinal Products for Human Use has granted the drug an accelerated assessment.
This fast-tracking means that the review timeline of the MAA is shortened from 210 days to 150 days. The acceleration is due to the global supply shortage caused by Genzyme temporarily shutting down its manufacturing facility in Boston in June after a bioreactor was contaminated with a virus which affected production of Cerezyme (imiglucerase).
Shire noted that velaglucerase alfa is already being supplied to Gaucher patients in Europe and outside the USA through pre-approval access programmes.
