The 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.
The company’s commercialization partner Pfizer will be responsible for marketing ELELYSO in Australia.
The US Food and Drug Administration (FDA) had already approved taliglucerase alfa for treatment of adults with Type 1 Gaucher disease in May 2012.
With the TGA approval, ELELYSO is now licensed in ten countries and further regulatory filings are underway.
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 company is focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx.