European Agency Recommends Gene Therapy Approval

redOrbit Staff & Wire Reports Your Universe Online A European Union agency for the evaluation of medicinal products is recommending the approval of a gene therapy treatment for a rare disease, which would be the first time a treatment of this kind has received the regulatory go-ahead for use in the West, according to various reports published Friday. A statement released by the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) officially recommended the authorization of Glybera (alipogene tiparvovec) for use throughout all EU member states. Glybera, which is manufactured by the Dutch firm uniQure, is used to treat lipoprotein lipase deficiency (LPLD), an extremely rare disorder that prevents people from digesting fat. Continue reading