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news.The US Food and Drug Administration (FDA) has accepted to review Protalix BioTherapeutics' resubmitted new drug application (NDA) of taliglucerase alfa.
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The resubmission was done following the issuing of complete response letter (CRL) by the FDA in February 2011.
Taliglucerase alfa is Pfizer‘s proprietary plant cell expressed recombinant form of human Glucocerebrosidase (GCD) which is being developed as a treatment for gaucher disease.
The company’s resubmission answers all the questions raised by the FDA in the CRL as well as 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).
Earlier, on 30 November 2009, Pfizer and Protalix signed a deal for the development and commercialization of taliglucerase alfa.
Protalix president and CEO David Aviezer said they look forward to working with the FDA in moving taliglucerase alfa through the regulatory review process over the next few months.