The National Institute for Health and Care Excellence (NICE) has recommended Chiesi’s Elfabrio (pegunigalsidase alfa) as a long-term option for treating Fabry disease in adults in England and Wales.
Chiesi Farmaceutici`s Elfabrio (Pegunigalsidase alfa) Receives Approval in the Europe
Chiesi's Biologic Elfabrio (Pegunigalsidase alfa) Receives Approval in the U.S.
The therapy becomes the first pegylated enzyme for the treatment of adult patients with Fabry disease
PRX–102 (pegunigalsidase alfa), the first and only pegylated enzyme for adults with Fabry disease has been recommended by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).
PARMA, Italy and BOSTON and CARMIEL, Israel, Feb. 24, 2023 /PRNewswire/ -- Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people affected by rare diseases, and Protalix Biotherapeutics, Inc., (NYSE American:PLX) (TASE:PLX), a biopharmaceutical company, announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending marketing authorization for PRX–102 (pegunigalsidase alfa), the first and only pegylated enzyme for the treatment of adult patients with Fabry disease.
CARMIEL, Israel and BOSTON, Dec. 5, 2022 /PRNewswire/ - Protalix BioTherapeutics, Inc. (NYSE American:PLX) (TASE:PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell based protein expression system, and Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people affected by rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmitted Biologics License Application (BLA) for pegunigalsidase alfa (PRX-102) for the proposed treatment of adult patients with Fabry disease. Pegunigalsidase alfa is a purposefully-designed, long-acting recombinant, PEGylated, cross-linked ?-galactosidase-A investigational product candidate. The FDA indicated in the BLA filing communication letter that the resubmitted BLA was considered a complete, class 2 response and set an action date of May 9, 2023, under the Prescription Drug User Fee Act (PDUFA).
Chiesi Global Rare Diseases, a business unit of privately-held Italian drugmaker Chiesi Farmaceutici, and Israeli firm Protalix BioTherapeutics (TASE: PLX) today announced final results from the Phase III BRIGHT study evaluating pegunigalsidase alfa (PRX-102) for the treatment of Fabry disease. Protalix’ shares gained nearly 15% in morning trading.
CARMIEL, Israel, Feb. 3, 2022 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American: PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell-based protein expression system, today announced that there will be two poster presentations regarding the Company's pegunigalsidase alfa or PRX–102 candidate under development for the treatment of Fabry disease at the 18th Annual WORLDSymposium™ 2022, taking place February 7-11, 2022 at the Manchester Grand Hyatt in San Diego, California.
The Israeli biotech received a complete response letter from the FDA for PRX–102, or pegunigalsidase alfa, in April, which iced the company’s plan to see the therapy through to a swift approval. The agency did not have any complaints about the safety of the therapy but said an inspection of Protalix's manufacturing facility in Karmiel, Israel, had to be completed. The inspection was unable to be conducted due to COVID-19 travel restrictions.