Protalix gets temporary approval for Gaucher drug taliglucerase in France
The French regulatory authority has granted an Autorisation Temporaire d'Utilisation (ATU), or Temporary Authorization for Use, for Israel-based Protalix BioTherapeutics' taliglucerase alfa for the treatment of Gaucher disease.
The drug, which has been given the trade name Uplyso, is licensed to US drugs behemoth Pfizer under a deal that could earn the Israeli firm as much as $115 million (The Pharma Letter December 2, 2009).
An ATU is the regulatory mechanism used by the French Health Products and Safety Agency to make non-approved drugs available to patients in France when a genuine public health need exists, in this case likely due to the now well-documented shortage of US biotech major Genzyme's established Gaucher drug Cerezyme (imiglucerase; TPLs passim).
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