Protalix Wins FDA Approval for Its First Drug on the Market

Bloomberg BusinessWeek (05/01/12) Edney, Anna
The FDA has granted approval to the debut medicine of Protalix BioTherapeutics, Elelyso (taliglucerase), which was developed with Pfizer for the treatment of Gaucher disease. Elelyso is approved to treat Type 1 Gaucher disease, a condition caused by the lack of an enzyme which can cause spleen and liver enlargement. The drug is the first approved made from genetically engineered plants, in this case carrot cells, and will be competing with Sanofi's Cerezyme, a mammalian cell-based treatment approved in 1994, and with Shire's Vpriv, which was approved in 2010. Protalix and Pfizer have indicated that they are prepared to supply all 2,000 patients on Gaucher treatment in the U.S. with Elelyso, a once-weekly injection, and Pfizer will keep a two-year supply in reserve for each patient prescribed the drug.

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