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25 Jul 2012

EU Moves Closer to Approving First Gene Therapy

The CHMP has issued a positive opinion on Glybera, which could soon become the first approved gene therapy in Europe.

The EU has taken a step closer to authorising its first gene therapy, after a European Medicines Agency (EMA) committee recommended a new medical treatment for approval.


The Committee for Medicinal Products for Human Use (CHMP) has recommended Glybera (alipogene tiparvovec) for the treatment of lipoprotein lipase (LPL) enzyme deficiency in patients with severe or multiple pancreatitis attacks.


Following the recommendation, the European Commission will now consider the advice and determine whether or not to authorise Glybera for marketing throughout the EU.


"The evaluation of this application has been a very complex

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