Shire says that it is now available to provide its new Gaucher disease drug “well over a year ahead of previously-anticipated commercial launch worldwide”.

The company has recently filed velaglucerase with the US Food and Drug Administration at a time when Gaucher patients and health authorities are looking to cope with a potential shortage of the only approved drug for the disease, Genzyme Corp's Cerezyme (imiglucerase). The latter firm temporarily shut down its manufacturing facility in Boston in June after a bioreactor was contaminated with a virus.

This has provided an opportunity for Shire and it has responded quickly. In the USA, the velaglucerase alfa treatment protocol is currently open and enrolling patients, while in the European Union and other areas, the firm says it is “engaging with national and regional authorities to seek pre-approval access using the fastest mechanisms available in each region”.

Shire added that it has accelerated its manufacturing timeline by almost 18 months in order to provide the drug “for the long-term treatment of Gaucher patients during 2009 and beyond”. The total number of patients it can treat is dependent on the individual’s weight and dose recommended by their physician, but Shire estimates this could translate into a range of 300 to 600 patients that can be treated, starting this month.

The company added that it also expects that “several hundred more patients can be added throughout 2010”. Shire went on to say that it is working with “a global group of experienced Gaucher physicians” to ensure that guidelines are put in place that “consider patients in the greatest need of treatment during the supply crisis”.