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Protalix and Chiesi Plan Q1 2020 Filing For Accelerated FDA Approval

 
• By Scrip Team

The companies plan to use surrogate endpoint data to win approval to challenge Sanofi and Shire for the Fabry disease market.

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Hoping For A Direct Shot

Protalix BioTherapeutics Inc. and Chiesi Farmaceutici SPA plan to file for accelerated approval of Fabry disease drug pegunigalsidase alfa in the first quarter of next year after talks with US Food and Drug Administration found a surrogate path forward.

The partners are testing the drug, also known as PRX-102, in three Phase III trials to establish it as a rival to Sanofi’s Fabrazyme and Shire PLC’s Replagal in the treatment of the rare genetic disease

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