Protalix BioTherapeutics, Inc. announced that the U.S. Food & Drug Administration (FDA) has accepted the resubmission of the taliglucerase alfa New Drug Application (NDA) for review, following the company’s receipt of a Complete Response Letter (CRL) in February 2011.
The FDA deemed the resubmission a class 2, or 6-month, response and established February 1, 2012 as the Prescription Drug User Fee Act (PDUFA) date. Taliglucerase alfa is the xompany’s proprietary plant cell expressed recombinant form of human Glucocerebrosidase (GCD) which is being developed for the treatment of Gaucher disease.
The company’s submission addresses the questions posed by the FDA in the CRL, including the request for clinical data from the company’s switchover trial and long-term extension trial, and additional information relating to chemistry, manufacturing and controls (CMC).
On November 30, 2009, Pfizer and Protalix BioTherapeutics, Inc. entered into an agreement to develop and commercialize taliglucerase alfa.
“Pfizer is ready to make taliglucerase alfa commercially available to Gaucher patients in the United States, if approved by the FDA,” notes said Diem Nguyen, general manager, Biosimilars.
Release Date: Aug. 17, 2011
Source: Protalix BioTherapeutics
Filed Under: Drug Discovery