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news.Protalix BioTherapeutics has received an Autorisation Temporaire d'Utilisation (ATU) or Temporary Authorisation for Use grant for Taliglucerase alfa, for the treatment of Gaucher disease, from French regulatory authority.
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Taliglucerase alfa is an enzyme replacement therapy that is expected to work by replacing the missing enzyme in Gaucher disease, helping to break down glucocerebroside and stopping it building up in the body.
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.
Protalix BioTherapeutics said that the ATU allows Taliglucerase alfa to be used as a treament for the patients with Gaucher disease in France, before marketing authorisation for the product is granted in the European Union.
David Aviezer, president and CEO of Protalix BioTherapeutics, said: “We are pleased to be able to provide Taliglucerase alfa to Gaucher patients in France under the ATU program.”
Protalix BioTherapeutics is a biopharmaceutical company focused on the development and commercialization of proprietary recombinant therapeutic proteins expressed through its proprietary plant cell based expression system.