EU Regulator Backs UniQure's Glybera As First Gene Therapy

Law360, New York (July 20, 2012, 12:00 AM EDT) -- Dutch biotech company uniQure’s Glybera, a gene therapy treatment for a rare fat processing disorder, is poised to become the first such treatment approved for use in the western world after the European Medicines Agency gave its nod to the drug on Friday.

Glybera, which targets the genetic disorder lipoprotein lipase deficiency, was approved after two previous rejections by EMA. Assuming EU approval, Glybera would be the first gene therapy treatment to be approved for use in both the EU and wider western world, EMA said. The agency did...
To view the full article, register now.