Israel-based biopharmaceutical firm Protalix BioTherapeutics has received approval from the Australian Therapeutic Goods Administration (TGA) for ELELYSO (taliglucerase alfa) for injection, as a long-term enzyme replacement therapy for treatment of Gaucher disease in both adult and pediatric patients.
Regulatory approval of the drug is for patients with a confirmed diagnosis of type 1 Gaucher disease associated with at least one of the following splenomegaly, hepatomegaly, anemia and thrombocytopenia.
Protalix’s commercialisation partner Pfizer will be responsible for marketing ELELYSO in Australia.
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By GlobalDataIn May 2012, the US Food and Drug Administration (FDA) approved taliglucerase alfa for treatment of adults with type 1 Gaucher disease.
With TGA approval, the drug is now licensed in ten countries and further regulatory filings are underway.
Protalix senior vice-president of product development Einat Brill Almon said Australia is the first country where ELELYSO is indicated for both adult and pediatric patients as the pediatric trials were completed concurrently with the TGA’s review beginning.
"In other countries where ELELYSO is currently approved, label expansions are being filed to include pediatric patients as well," Almon said.
ELELYSO is the first plant cell-expressed enzyme replacement therapy (ERT) derived from ProCellEx, the company’s plant cell-based protein manufacturing system, using genetically engineered carrot cells.
The drug is a form of the human lysosomal enzyme, glucocerebrosidase, used to treat Gaucher disease.
Protalix president and chief executive officer David Aviezer said Australian approval of ELELYSO is an important achievement and a testament to the company’s partnership with Pfizer.
"We are delighted that the TGA has approved ELELYSO for the treatment of Gaucher disease, providing an alternative treatment option for these patients," Aviezer said.
Protalix is focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx.
Image: Micrograph showing crinkled paper macrophages in the marrow space in a case of Gaucher disease. Photo: courtesy of Nephron.
