Delivering more
days near
normal

Only ALTUVIIIO provided Factor VIII activity levels in the normal to near-
normal (>40%) range for most of the week in the Phase 1 study1,2*

PHASE 1 SEQUENTIAL PK STUDY1

Chart displaying ALTUVIIIO’s extended half-life and higher levels of Factor VIII compared to other therapies

Lower interpatient variability vs an SHL and EHL* was
observed in the Phase 1 study across PK parameters1†

* Data from a Phase 1 trial in 13 previously treated adults with severe hemophilia A. Pharmacokinetic profiles of ALTUVIIIO, Advate® [Antihemophilic Factor (Recombinant)], and Adynovate® [Antihemophilic Factor (Recombinant), PEGylated] were evaluated after sequential IV infusions. Primary objective: assess the elimination half-life for each product. Secondary objectives: characterization of additional PK parameters; evaluation of safety and tolerability of ALTUVIIIO.1

Lower interpatient variability assessed across PK parameters (AUC, half-life, clearance) was also seen in XTEND-1.3
Advate and Adynovate are registered trademarks of Baxalta Incorporated, a Takeda company.

Normal to near-
normal Factor
VIII activity
levels for most
of the week
were also seen
in the Phase 3
XTEND-1 trial*

PHASE 3 XTEND-1 SEQUENTIAL PK
SUBGROUP (n=17)3

Chart displaying ALTUVIIIO’s normal to near-normal Factor VIII activity levels replicated in the Phase 3 XTEND-1 sequential PK subgroup trial with 17 patients

XTEND-1 TRIAL ADULT STUDY POPULATION (n=124)2,3

Once-weekly ALTUVIIIO provided

  • ~4 days with Factor VIII levels above 40% (normal to near-normal range)2
  • Factor VIII trough levels of 18%2†
    • Factor VIII clearance has been demonstrated to be higher in patients <18 years, resulting in lower trough levels2

The pharmacokinetic profile was similar after the first dose and after 26 weeks of weekly dosing. A steady state was achieved after the first dose of ALTUVIIIO.2

Once-weekly 50 IU/kg ALTUVIIIO provided Factor VIII activity levels that were associated with a low bleed risk2

*Data from the Phase 3 XTEND-1 study in 134 adults (aged 18 and older) receiving a weekly IV infusion of 50 IU/kg ALTUVIIIO. PK parameters shown are based on plasma Factor VIII activity measured by the aPTT-based one-stage clotting assay.2,3

Mean trough level observed at Week 52/end of study PK sampling visit for the adult population in the XTEND-1 study (n=124).2

Mechanisms of half-life extension (MOE)

Achieving
high sustained
mean Factor VIII
levels (>40%) for
most of the week by
overcoming the
half-life limitations
of von Willebrand
Factor (vWF)2,4,5

The half-life of factor VIII is extended
with natural amino acids2,4,5*

Infographic: ALTUVIIIO molecule with three components annotated Fc Domain, XTEN® Polypeptides, and vWF D’D3 Domain

ALTUVIIIO IS UNIQUELY DESIGNED TO BE INDEPENDENT OF THE vWF CHAPERONE

*ALTUVIIIO is composed of naturally occurring amino acids that are able to be broken down through regular protein degradation processes.  4

The half-life
of factor VIII
is extended
with
natural amino acids2,4,5*

Altuviiio Logo

FACTOR FVIII

At the core of
ALTUVIIIO
is rFVIII, which
replaces deficient
FVIII in patients
with hemophilia A

Altuviiio Logo

Fc DOMAIN

Delays FVIII
degradation,
and helps FVIII stay
in circulation by
slowing the
clearance rate

Altuviiio Logo

XTEN® POLYPEPTIDE INSERTION

Shields the FVIII
molecule from
proteolytic
degradation, and
reduces binding
to clearance
receptors

Altuviiio Logo

vWF D’D3 DOMAIN

Prevents binding
of FVIII to
endogenous vWF

ALTUVIIIO IS UNIQUELY
DESIGNED TO BE
INDEPENDENT OF THE
vWF CHAPERONE

*ALTUVIIIO is composed of naturally occurring amino acids that are able to be broken down through regular protein degradation processes.  4

Discover how
ALTUVIIIO achieves
high sustained
mean Factor VIII
levels (>40%) for
most of the week1,2

In a Phase 3 study, ALTUVIIIO offered a 48.2-hour
half life in adults — the longest of any Factor VIII
replacement therapy2,6-18†

Comparison of data from XTEND-1 with half-life data recorded in prescribing information of approved Factor VIII replacement therapies.

Learn how
ALTUVIIIO
was studied

XTEND-1 trial studied
ALTUVIIIO in the
prophylaxis,
on-demand,
and perioperative settings.

EXPLORE THE XTEND-1 TRIAL

INDICATION

ALTUVIIIO® [antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl] is a von Willebrand Factor (VWF) independent recombinant DNA-derived, Factor VIII concentrate indicated for use in adults and children with hemophilia A (congenital factor VIII deficiency) for:

  • Routine prophylaxis to reduce the frequency of bleeding episodes
  • On-demand treatment & control of bleeding episodes
  • Perioperative management of bleeding

Limitation of Use

ALTUVIIIO is not indicated for the treatment of von Willebrand disease.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

ALTUVIIIO is contraindicated in patients who have had severe hypersensitivity reactions, including anaphylaxis, to the product or its excipients.

WARNINGS AND PRECAUTIONS

  • Allergic-type hypersensitivity reactions, including anaphylaxis, may occur with ALTUVIIIO. Allergic-type hypersensitivity reactions were not reported in the clinical trials. Advise patients to discontinue use of ALTUVIIIO if hypersensitivity symptoms occur and contact a physician and/or seek immediate emergency care.
  • Formation of neutralizing antibodies (inhibitors) to Factor VIII is possible following administration of ALTUVIIIO. Neutralizing antibodies were not reported in the clinical trials. Monitor all patients for the development of Factor VIII inhibitors by appropriate clinical observations and laboratory tests.
  • If assessment of plasma Factor VIII activity is needed, it is recommended to use a validated one-stage clotting assay. The ALTUVIIIO Factor VIII activity level is overestimated by the chromogenic assay and a specific ellagic acid-based aPTT reagent in one-stage clotting assay by approximately 2.5-fold. If these assays are used, divide the result by 2.5 to approximate the patient's ALTUVIIIO Factor VIII activity level.

ADVERSE REACTIONS

The most common adverse reactions (>10% of subjects) reported in clinical trials were headache and arthralgia.

See full Prescribing Information.

Learn more about Sanofi’s commitment to fighting counterfeit drugs.

aPTT=activated partial thromboplastin time; AUC=area under the curve; IU=international units; IV=intravenous; PK=pharmacokinetics; rFVIII=recombinant Factor VIII; SD=standard deviation; vWF=von Willebrand factor.

INDICATION

ALTUVIIIO® [antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl] is a von Willebrand Factor (VWF) independent recombinant DNA-derived, Factor VIII concentrate indicated for use in adults and children with hemophilia A (congenital factor VIII deficiency) for:

  • Routine prophylaxis to reduce the frequency of bleeding episodes
  • On-demand treatment & control of bleeding episodes
  • Perioperative management of bleeding

Limitation of Use

ALTUVIIIO is not indicated for the treatment of von Willebrand disease.

IMPORTANT SAFETY INFORMATION

ALTUVIIIO is contraindicated in patients who have had severe hypersensitivity reactions, including anaphylaxis, to the product or its excipients.

WARNINGS AND PRECAUTIONS

  • Allergic-type hypersensitivity reactions, including anaphylaxis, may occur with ALTUVIIIO. Allergic-type hypersensitivity reactions were not reported in the clinical trials. Advise patients to discontinue use of ALTUVIIIO if hypersensitivity symptoms occur and contact a physician and/or seek immediate emergency care.
  • Formation of neutralizing antibodies (inhibitors) to Factor VIII is possible following administration of ALTUVIIIO. Neutralizing antibodies were not reported in the clinical trials. Monitor all patients for the development of Factor VIII inhibitors by appropriate clinical observations and laboratory tests.
  • If assessment of plasma Factor VIII activity is needed, it is recommended to use a validated one-stage clotting assay. The ALTUVIIIO Factor VIII activity level is overestimated by the chromogenic assay and a specific ellagic acid-based aPTT reagent in one-stage clotting assay by approximately 2.5-fold. If these assays are used, divide the result by 2.5 to approximate the patient's ALTUVIIIO Factor VIII activity level.

ADVERSE REACTIONS

The most common adverse reactions (>10% of subjects) reported in clinical trials were headache and arthralgia.

Please see full Prescribing Information.

Learn more about Sanofi’s commitment to fighting counterfeit drugs.

aPTT=activated partial thromboplastin time; PK=pharmacokinetics.