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CHMP Recommends EU's First Gene Therapy Product
Posted 20 July 2012 | By
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended for use the first gene therpy product in the European Union, regulators said Friday, 20 July.
Glybera (alipogene tiparvovec), manufactured by UniQure, is intended to treat lipoprotein lipase deficiency-an ultra-rare disease that renders patients unable to break down dietary fat.
Current therapies for the disease are dietary oriented, with patients required to eat ultra-low-fat diets or risk hospitalization with pancreatitis.
Glybera represents not only the first medical treatment for the disease, but also the first gene therapy product recommended in the EU, wrote EMA. Tomas Salmonson, acting Chair of the CHMP said the approvals process had "been a very complex process," resulting in the product being recommended for a narrower indication of patients than originally sought by AMTH.
The committee's recommendations states the product must be administered only by a physician with "expertise in treating patients with lipoprotein lipase deficiency and in gene therapy administration"-likely a testament to the product's rocky and contentious approvals process thus far.
Glybera must now be approved by the European Commission before it is allowed to be marketed.
EMA - European Medicines Agency recommends first gene therapy for approval
CHMP - Summary of positive opinion for Glybera