Protalix BioTherapeutics, Inc., announced today it has submitted validation data regarding the company’s manufacturing process for taliglucerase alfa to the U.S. Food and Drug Administration (FDA). The company made the submission in response to a request from the FDA for validation data from the Company’s upgraded manufacturing facility. The FDA is currently reviewing the company’s New Drug Application (NDA) for taliglucerase alfa for the treatment of Gaucher disease.
Taliglucerase alfa has been granted orphan drug status and fast track designation in the United States. The Company continues to make taliglucerase alfa available to Gaucher patients in the United States under an Expanded Access protocol, as well as to patients in the European Union, Israel and other countries under Named Patient provisions.