Pfizer and Protalix BioTherapeutics announced that the FDA has approved Elelyso (taliglucerase alfa) injection for the treatment of Type 1 Gaucher disease. Elelyso is the first FDA-approved plant cell-based enzyme replacement therapy (ERT) for management of Gaucher disease.
The approval of Elelyso was based on results from two Phase 3 clinical trials. One study assessed the safety and efficacy of Elelyso in 31 adult patients with Type 1 Gaucher disease naïve to enzyme replacement therapy. Results showed that Elelyso significantly reduced spleen volume after nine months compared to baseline in both treatment groups. The second study assessed the safety and efficacy of Elelyso in 25 patients with Type 1 Gaucher disease who were switched from imiglucerase (Cerezyme injection; Genzyme) to Elelyso. Results showed that organ volumes and hematologic values remained stable on average through nine months of Elelyso treatment.
Elelyso injection is a hydrolytic lysosomal glucocerebroside-specific enzyme indicated for long-term enzyme replacement therapy.
For more information call (855) 353-5976 or visit www.elelyso.com.