The European Commission on Monday approved a new dosing regimen for Elfabrio, an enzyme replacement therapy jointly developed by Protalix BioTherapeutics, Inc. (PLX) and Chiesi Farmaceutici S.p.A.'s rare disease unit, for the treatment of adults with Fabry disease who are stable on enzyme replacement therapy.
The updated regimen allows a 2 mg per kg dose to be administered every four weeks, extending the previous two-week treatment interval.
The approval follows a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use and was supported by results from the BRIGHT clinical study evaluating the safety and efficacy of the extended dosing schedule.
Protalix will receive a $25 million regulatory milestone payment from Chiesi following the approval.
PLX is currently trading at $2.80, up $0.18 or 7.06 percent on the New York Stock Exchange.
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