Protalix BioTherapeutics said that the FDA has granted taliglucerase alfa a standard review time of 10 months, assigning a prescription drug user fee act (PDUFA) action date of February 25, 2011.
Taliglucerase alfa is the Protalix BioTherapeutics’ proprietary plant cell expressed recombinant form of human Glucocerebrosidase (GCD) which is being developed under a Special Protocol Assessment (SPA) with the FDA for the treatment of Gaucher disease.
Protalix BioTherapeutics completed the submission of a rolling NDA with the FDA in April 2010, following the completion of a Phase III clinical trial of Taliglucerase alfa.
Protalix BioTherapeutics stated that Taliglucerase alfa has received orphan drug designation from the FDA in the US. The company continues to make Taliglucerase alfa available to Gaucher patients in the US under an Expanded Access protocol, as well as to patients in the European Union, Israel and other countries under Named Patient provisions.
David Aviezer, president and CEO of Protalix, said: “If approved, taliglucerase alfa is expected to be an important therapeutic option for Gaucher patients. We look forward to working closely with the agency through this final stage of the review process.”