Protalix, Chiesi Global: CHMP issues negative opinion for Elfabrio

Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people living with rare diseases, and Protalix (PLX) BioTherapeutics acknowledge that the Committee for Medicinal Products for Human Use of the European Medicines Agency has issued a negative opinion on the request to approve the dosing regimen of 2 mg/kg body weight infused every 4 weeks for Elfabrio. “We are disappointed by the result of this review but want to express our immense appreciation for the collaboration of the patient community, researchers and European Commission throughout this process,” said Giacomo Chiesi, Executive Vice President, Chiesi Global Rare Diseases. “We are proud to be a part of this community and will continue to prioritize the potential to advance and evolve safe and effective solutions for Fabry disease with reduced treatment burden.”