Posted by Michael Wonder on 05 Aug 2015
Pfizer and Protalix BioTherapeutics announce FDA approval of pediatric indication for Elelyso (taliglucerase alfa) for injection, for intravenous use for the treatment of Type 1 Gaucher disease
Pfizer Inc. and Protalix BioTherapeutics, Inc. announced today that the U.S. Food and Drug Administration (FDA) approved Elelyso (taliglucerase alfa) for injection for pediatric patients. Elelyso is therefore now indicated for long-term enzyme replacement therapy (ERT) for adult and pediatric patients with a confirmed diagnosis of Type 1 Gaucher disease.
"The approval of Elelyso to treat pediatric patients with Type 1 Gaucher disease provides physicians another treatment option for this rare and potentially debilitating disease,” said Rory O’Connor, Senior Vice President, Global Medical Affairs, Global Innovative Pharma Business, Pfizer Inc. “This pediatric indication, along with the recent announcement that Elelyso received kosher certification by the Orthodox Union (OU), reinforces the ongoing commitment of Pfizer to addressing the needs of the Gaucher community.”
