Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to the Israel-based Protalix Biotherapeutics regarding its New Drug Application (NDA) for taliglucerase alfa indicated for the treatment of gaucher disease.
Subscribe to our email newsletter
Taliglucerase alfa is a plant-cell expressed form of the enzyme glucocerebrosidase (GCD).
Taliglucerase is the first product for Protalix, and works by replacing an enzyme missing in people with gaucher disease.
The FDA has asked for more data from two studies, as well as additional information on testing specifications in the new drug application.
In the clinical section, the FDA has requested additional data from the switchover trial and long-term extension trial.
In the manufacturing and controls section, the FDA has requested information on testing specifications and assay validation.
While patient enrollment remains open in Protalix’s multi-center, double-blind pediatric trial of taliglucerase alfa, the company will now request a meeting with the FDA at the earliest to obtain regulatory approval.
Pfizer and Protalix had collaborated to develop and commercialize taliglucerase alfa in November 2009, and the former is entitled to 60% of the drug’s revenue under the licensing agreement.