Posted on 31/08/2010 in Pharmaceutical Company Product News Shire has been granted approval from European regulators for the sale of Vpriv, its new treatment for type 1 Gaucher disease.
The European Commission has given marketing authorisation to the human cell line-derived enzyme replacement therapy following a series of clinical trials, all of which met their primary endpoints.
Vpriv has been ratified as an orphan medicine via the commission's Centralised Procedure, making it available in 30 countries across the continent.
The drug has already been made available to several hundred Gaucher disease sufferers in Europe via early access programmes, with Shire set to work towards ensuring these patients' treatment regime can continue uninterrupted.
Sylvie Gregoire, president of Shire Human Genetic Therapies, said: "Our efforts to accelerate our manufacturing, clinical and regulatory timelines have resulted in Vpriv's approval in Europe and the US months ahead of schedule."
Earlier this month, Shire announced the sale of its attention deficit hyperactivity disorder therapy Daytrana to Noven Pharmaceuticals, with rights to the treatment set to be returned on October 1st 2010. Other news stories from 31/08/2010
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