Elelyso Approved for Type 1 Gaucher Disease
Every-other-week professionally administered injection
TUESDAY, May 1 (HealthDay News) -- Elelyso (taliglucerase alfa) has been approved by the U.S. Food and Drug Administration as a long-term enzyme replacement therapy for people with Type 1 Gaucher disease.
Elelyso, an every-other-week professionally administered injection, was clinically evaluated in a study of 56 people with type 1 Gaucher disease. The most common side effects included allergic reactions, headache, chest pain, fatigue, increased blood pressure, back or joint pain, and flushing.
"Today's approval provides for a new enzyme replacement therapy for the select number of patients with Type 1 Gaucher disease," said Julie Beitz, M.D., director of the Office of Drug Evaluation III in FDA's Center for Drug Evaluation and Research, in a statement. "It also demonstrates FDA's commitment to developing treatments for rare diseases."
Elelyso is produced and distributed by New York City-based Pfizer, under license from Protalix BioTherapeutics.
Medline Plus has more about Gaucher disease.