Protalix BioTherapeutics and Chiesi Farmaceutici S.p.A to Apply for Accelerated Approval of pegunigalsidase alfa for the Treatment of Fabry Disease in the United States
Protalix BioTherapeutics, Inc. (DE) (PLX)
NASDAQ:AMEX Investor Relations:
phx.corporate-ir.net/phoenix.zhtml?c=101161&p=irol-irhome
Company Research
Source: GlobeNewswire
CARMIEL, Israel, June 06, 2019 (GLOBE NEWSWIRE) -- Protalix BioTherapeutics, Inc. (NYSE American: PLX) (TASE: PLX), or Protalix, and Chiesi Farmaceutici S.p.A, an international research-focused healthcare Group, or Chiesi, today announced that, following a series of meetings and correspondence with the U.S. Food and Drug Administration (FDA), they plan to file a biologics license application, or a BLA, for pegunigalsidase alfa for the treatment of Fabry disease in the first quarter of 2020 via the FDA’s Accelerated Approval pathway. Over the last several months, Protalix and Chiesi have engaged the FDA in a dialogue regarding the potential eligibility of pegunigalsidase alfa for accelerated approval based on readily available data generated by Protalix from its clinical studies of pegunigalsidase alfa. As a result of this dialogue and a recent letter received from the FDA, Protalix and Chiesi have initiated preparations for a BLA submission based on data from the completed phase I
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