PRX-102 (pegunigalsidase alfa) — Competitive Intelligence Brief

PRX-102 (pegunigalsidase alfa) (PRX-102 (pegunigalsidase alfa)) competitive landscape: 3 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Enzyme replacement therapy (ERT). Area: Rare genetic disease / Lysosomal storage disorder.

phase 3 Enzyme replacement therapy (ERT) α-galactosidase A (GLA) Rare genetic disease / Lysosomal storage disorder Biologic

Target snapshot

PRX-102 (pegunigalsidase alfa) (PRX-102 (pegunigalsidase alfa)) — Protalix. PRX-102 is a pegylated recombinant human α-galactosidase A enzyme that breaks down accumulated globotriaosylceramide (Gb3) in cells affected by Fabry disease.

Comparator set (3 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
PRX-102 (pegunigalsidase alfa) TARGET	PRX-102 (pegunigalsidase alfa)	Protalix	phase 3	Enzyme replacement therapy (ERT)	α-galactosidase A (GLA)
Fabrazyme (agalsidase beta)	Fabrazyme (agalsidase beta)	Genzyme, a Sanofi Company	marketed	Enzyme replacement therapy (ERT); recombinant enzyme	α-galactosidase A (GLA gene product); substrate: globotriaosylceramide (GL-3)
Fabagal® (Agalsidase beta)	Fabagal® (Agalsidase beta)	ISU Abxis Co., Ltd.	phase 3	Enzyme replacement therapy (ERT)	α-galactosidase A (GLA enzyme)
Alglucosidase alfa (GZ419829)	Alglucosidase alfa (GZ419829)	Genzyme, a Sanofi Company	phase 3	Enzyme replacement therapy (ERT)	Acid alpha-glucosidase (GAA)

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (Enzyme replacement therapy (ERT) class)

1. Genzyme, a Sanofi Company · 1 drug in this class
2. ISU Abxis Co., Ltd. · 1 drug in this class
3. Protalix · 1 drug in this class