Genzyme, a Sanofi company, announced today that the U.S. Food and Drug Administration (FDA) has approved Cerdelga (eliglustat) capsules, the only first-line oral therapy for certain adult Gaucher disease type 1 patients. A small number of adult patients who metabolize Cerdelga more quickly or at an undetermined rate, as detected by an established genetic laboratory test, will not be eligible for Cerdelga treatment. Cerdelga is expected to be available to patients within a month.
“Cerdelga is an important new option for people living with Gaucher disease type 1,” said Rhonda Buyers, CEO of the National Gaucher Foundation. “As enzyme replacement therapy is the standard of treatment for Gaucher disease, patients receive regular intravenous infusions for life. With FDA's approval of a first-line oral treatment, Cerdelga has the potential to be a valuable treatment option for people living with this serious disease.”
For more details, go to: http://news.genzyme.com/press-release/fda-approves-genzymes-cerdelga-eliglustat-capsules