"This approval unlocks the potential of gene therapy because it is a first at either the EMA or FDA (U.S. Food and Drug Administration) for gene therapy, " uniQure's chief executive Jorn Aldag said in an interview.
On April 28 Dendreon of Seattle notched Food and Drug Administration approval for Provenge, its cell therapy designed to train the immune system to fight prostate cancer.
An advisory panel to the U.S. Food and Drug Administration unanimously voted Nov. 14 that Roche's new combination therapy for hepatitis C should be approved.
The current standard treatment cures between 66% and 79% of patients with the most common type of hepatitis C, known as genotype 1, and who are undergoing the drug therapy for the first time, according to clinical data cited by the Food and Drug Administration.