Alglucosidase alfa (GZ419829) — Competitive Intelligence Brief

Alglucosidase alfa (GZ419829) (Alglucosidase alfa (GZ419829)) competitive landscape: 3 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Enzyme replacement therapy (ERT). Area: Rare Genetic Disorder / Metabolic Disease.

phase 3 Enzyme replacement therapy (ERT) Acid alpha-glucosidase (GAA) Rare Genetic Disorder / Metabolic Disease Small molecule

Target snapshot

Alglucosidase alfa (GZ419829) (Alglucosidase alfa (GZ419829)) — Genzyme, a Sanofi Company. Alglucosidase alfa is a recombinant human acid alpha-glucosidase enzyme that breaks down glycogen accumulated in lysosomes in Pompe disease.

Comparator set (3 drugs)

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

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