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Chiesi's Commercial Hopes In US Hit By FDA Letter

Protalix-Partnered Fabry Drug Turned Down By Agency

 
• By Kevin Grogan

Shares in Protalix sank more than 30% after the company received a complete response letter from US regulators for pegunigalsidase alfa for Fabry disease. No inspection of the company's manufacturing plant in Israel appears to be the main sticking point.

travel disrupt
COVID-19 travel restrictions prevented inspection of Protalix facility • Source: Alamy

Protalix BioTherapeutics, Inc. and Chiesi Farmaceutici S.p.A. have been stunned by rejection in the US for pegunigalsidase alfa, a decision that appears to have been driven by COVID-19 travel restrictions preventing an inspection of the manufacturing facility for their eagerly anticipated Fabry disease therapy.

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