FDA approves Elelyso for pediatric use in Gaucher disease

The US Food and Drug Administration has approved US pharma giant Pfizer’s (NYSE: PFE) Elelyso (taliglucerase alfa) for injection for pediatric patients with Type 1 Gaucher disease.

Elelyso, which has been developed with Israel’s Protalix Therapeutics (TSE: PLX), 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, of Pfizer’s Global Innovative Pharma Business, adding: “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.”