UniQure Won’t Seek U.S. Regulatory Approval for Glybera Gene Therapy Program

Dutch drugmaker uniQure has decided it won’t pursue FDA approval for its gene therapy Glybera for treatment of metabolic disorder lipoprotein lipase deficiency.

That decision largely is due to the additional clinical studies the FDA indicated it would require for the product, uniQure CEO Jörn Aldag said during a conference call. Aldag also cited the company’s prioritized investments in other programs.

The European Commission approved Glybera (alipogene tiparvovec) in 2012, making it the first gene therapy approved by regulatory authorities in the Western world.