BAY94-9027 — Competitive Intelligence Brief

BAY94-9027 (BAY94-9027) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Long-acting recombinant factor VIII (PEGylated). Area: Hematology.

phase 3 Long-acting recombinant factor VIII (PEGylated) Coagulation factor VIII Hematology Biologic

Target snapshot

BAY94-9027 (BAY94-9027) — Bayer. BAY94-9027 is a long-acting factor VIII replacement therapy that extends the half-life of clotting factor VIII through PEGylation, reducing dosing frequency in hemophilia A patients.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
BAY94-9027 TARGET	BAY94-9027	Bayer	phase 3	Long-acting recombinant factor VIII (PEGylated)	Coagulation factor VIII
Recombinant Factor VIII (rAHF)	Recombinant Factor VIII (rAHF)	Baxalta now part of Shire	marketed	Recombinant clotting factor	Coagulation Factor VIII
Moroctocog alfa (AF-CC)	Moroctocog alfa (AF-CC)	Pfizer	marketed	Recombinant coagulation factor VIII	Coagulation factor VIII
Afstyla®	Afstyla®	CSL Behring	marketed	Recombinant clotting factor VIII	Factor VIII (coagulation factor VIII)
Kogenate (BAY14-2222)	Kogenate (BAY14-2222)	Bayer	marketed	Recombinant coagulation factor VIII	Coagulation factor VIII
Intravenous infusions of Xyntha	Intravenous infusions of Xyntha	Pfizer	marketed	Recombinant coagulation factor VIII	Coagulation factor VIII
Recombinant Human Coagulation FVIII	Recombinant Human Coagulation FVIII	Sinocelltech Ltd.	marketed	Coagulation factor replacement therapy	Coagulation Factor VIII

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 (Long-acting recombinant factor VIII (PEGylated) class)

1. Bayer · 1 drug in this class