Protalix submits CRL reply to FDA on Gaucher drug taliglucerase; reports new trial data

USA-based Protalix BioTherapeutics (NYSE-AMEX: PLX) says it has submitted its reply to the Complete Response Letter issued by the Food and Drug Administration after its review of the company’s New Drug Application for taliglucerase alfa (The Pharma Letter February 28).

Taliglucerase alfa, the company’s proprietary plant-cell expressed form of glucocerebrosidase (GCD), is in development for the treatment of Gaucher disease. The company expects the FDA to provide an updated Prescription Drug User Fee Act (PDUFA) target action date within weeks, which is consistent with FDA guidelines.

"We believe we have adequately addressed the requests that were outlined by the FDA in their Complete Response Letter," said David Aviezer, president and chief executive of Protalix, adding: "We will continue to work closely with the FDA as it moves forward with the NDA review.”