FVIII (PK subgroup only) — Competitive Intelligence Brief

FVIII (PK subgroup only) (FVIII (PK subgroup only)) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Coagulation factor replacement. Area: Hematology.

phase 3 Coagulation factor replacement Factor VIII (coagulation cascade cofactor) Hematology Small molecule

Target snapshot

FVIII (PK subgroup only) (FVIII (PK subgroup only)) — Bioverativ Therapeutics Inc.. FVIII is a recombinant coagulation factor VIII that replaces deficient or dysfunctional clotting factor to restore hemostasis in hemophilia A patients.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
FVIII (PK subgroup only) TARGET	FVIII (PK subgroup only)	Bioverativ Therapeutics Inc.	phase 3	Coagulation factor replacement	Factor VIII (coagulation cascade cofactor)
Coagulation Factor VIII	Coagulation Factor VIII	Beijing Children's Hospital	marketed	Coagulation factor replacement	Coagulation Factor VIII (antihemophilic factor)
Factor IX recovery	Factor IX recovery	Wyeth is now a wholly owned subsidiary of Pfizer	marketed	Coagulation factor replacement	Factor IX (coagulation factor IX)
OctaplasLG®	OctaplasLG®	Rigshospitalet, Denmark	marketed	Plasma product; coagulation factor replacement	Multiple coagulation factors (I, II, V, VII, VIII, IX, X, XI, XII)
Recombinant Human Coagulation FVIII	Recombinant Human Coagulation FVIII	Sinocelltech Ltd.	marketed	Coagulation factor replacement therapy	Coagulation Factor VIII
von Willebrand factor	von Willebrand factor	National Center for Research Resources (NCRR)	marketed	Coagulation factor replacement	Von Willebrand factor receptor (GPIb-IX-V complex on platelets); Factor VIII binding site
FIX	FIX	Bioverativ Therapeutics Inc.	marketed	Recombinant coagulation factor replacement	Factor IX (coagulation cascade)

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 (Coagulation factor replacement class)

1. Beijing Children's Hospital · 1 drug in this class
2. Bioverativ Therapeutics Inc. · 1 drug in this class
3. Hoffmann-La Roche · 1 drug in this class
4. National Center for Research Resources (NCRR) · 1 drug in this class
5. Takeda · 1 drug in this class
6. Wyeth is now a wholly owned subsidiary of Pfizer · 1 drug in this class