Protalix Finalizes Accelerated Approval Pathway For PRX-102
Zacks Investment Research | Nov 18, 2019 09:26PM ET
Protalix BioTherapeutics, Inc. (NYSE:PLX) and its Italian partner Chiesi Farmaceutici S.p.A. announced that they have successfully completed a type B pre-Biologics License Application (“BLA”) meeting with the FDA regarding the accelerated approval pathway for their lead pipeline candidate, pegunigalsidase alfa (PRX-102). The companies are looking to get the candidate approved for treating Fabry disease, a rare inherited genetic lysosomal disorder.
Shares of Protalix surged 32.3% on Nov 18 following the announcement. However, the company’s shares have declined 17% so far this year against the industry ’s growth of 2.4%.
Protalix is a small biotech, focusing on the development of recombinant therapeutic proteins developed using its proprietary ProCellEx plant cell-based protein expression system for treating rare diseases.
Per the meeting, data from the previously completed phase I/II study on pegunigalsidase alfa and the ongoing phase III BRIDGE study will be included in the BLA. The regulatory application is expected to be filed with the FDA by April 2020.
The BRIDGE study evaluated pegunigalsidase alfa in patients with Fabry disease, who received treatment with Sanofi’s (NASDAQ:SNY) Fabry disease medicine Replagal (agalsidase alfa) for at least two years and were on a stable dose for at least six months. Interim data from the study announced last month looked promising and the candidate was well tolerated in patients.
Moreover, in the meeting, Protalix finalized the enrollment target for its confirmatory phase III study — BALANCE — evaluating pegunigalsidase alfa in Fabry disease. Data from the study will support continued approval for the candidate, if approved under accelerated approval pathway.
The BALANCE study is designed to evaluate the safety and efficacy of pegunigalsidase alfa compared to Sanofi’s another Fabry disease drug, Fabrazyme (agalsidase beta), on renal function in Fabry patients with progressing kidney disease, who have been previously treated with Replagal.
BALANCE is the third phase III study on PRX-102. The first two studies — BRIDGE and BRIGHT — are both fully enrolled and ongoing.
Protalix BioTherapeutics, Inc. Price
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