Tous Actualités
Suivre
Abonner Baxter Healthcare SA

Baxter Healthcare SA

Baxter Announces European Union Expanded Approval of ADVATE for use in Children With Haemophilia A Less Than Six Years Old

Zurich, Switzerland (ots/PRNewswire)

Baxter Healthcare S.A.
announced today that the European Commission has  granted expanded
approval of ADVATE(R) (Octocog Alfa Recombinant Coagulation  Factor
VIII), for use in children with haemophilia A under six years of age.
This expanded approval was granted on the basis of interim data
from 40 of 53 paediatric patients enrolled in a Phase III clinical
study. The study was conducted in 23 haemophilia treatment centers in
Europe and the United States, and assessed the pharmacokinetics,
safety, efficacy and immunogenicity of ADVATE in previously treated
haemophilia A patients less than six years of age.
The interim results showed an excellent/good bleed control
response rate in 92.4 percent of the treatments, and a fair rating in
7.6 percent. No adverse events were deemed related to the study drug
and no inhibitors were reported over a median of 74.0 exposure days.
No patient has withdrawn from the study due to an adverse event.
The safety and efficacy profile of ADVATE in children and adults
are comparable, with slightly different pharmacokinetic properties in
adults, but with similar bleed control response ratings, a low
incidence of drug-related adverse events and low inhibitor risk in
previously treated patients. These data suggest that ADVATE is
efficacious and well-tolerated for the prevention and treatment of
bleeding episodes in previously treated paediatric patients with
haemophilia A.
ABOUT BAXTER
Baxter Healthcare S.A. is the principal European operating
subsidiary of Baxter International Inc. Baxter International Inc.,
through its subsidiaries, assists health-care professionals and their
patients with treatment of complex medical conditions, including
cancer, haemophilia, immune disorders, kidney disease and trauma. The
company applies its expertise in medical devices, pharmaceuticals and
biotechnology to make a meaningful difference in patients' lives.
Facts About ADVATE
    Advanced Category of Haemophilia A Treatment
    - ADVATE (Octocog Alfa Recombinant Coagulation Factor VIII)
    is approved in Europe and the US for the treatment of
    bleeding episodes in people with haemophilia A. In Europe,
    ADVATE is also approved for prophylaxis.
    - ADVATE is the only recombinant factor VIII that
    eliminates potential blood-borne pathogen risk by using a
    plasma/albumin-free method and combines it with the
    heritage and proven efficacy of the RECOMBINATE molecule.
    - ADVATE is the only haemophilia A therapy made without any
    added human or animal plasma proteins and albumin in the
    cell culture process, purification and final formulation.
    Based on this innovative procedure, ADVATE eliminates the
    potential risk of infections caused by pathogens that may
    be carried in these protein additives.
    Human and/or Animal Derived Plasma/Albumin Presence in
    Development Process
        Recombinant Cell    Purification  Formulation
        Therapy     Culture
        1st           x          x
        Generation
        Next          x          x           NONE
        Generation
        ADVATE       NONE       NONE         NONE
        Advanced
        Category
    - ADVATE was developed using the most advanced processing
    for haemophilia treatments to date. ADVATE has a similar
    full-length molecular structure to the currently
    most-prescribed treatment, RECOMBINATE, but eliminates the
    potential pathogen risk associated with the use of animal-
    and human-derived plasma protein additives.
    - ADVATE is administered directly into the bloodstream and
    works by temporarily raising the level of factor VIII in
    the blood, thus allowing the body's blood clotting process
    to function properly.
    Why Develop ADVATE?
    - The haemophilia community has requested safer
    treatment options that further reduce the potential
    risk of contracting existing or emerging infectious
    diseases that continue to be of concern with the blood
    supply[1], such as West Nile Virus and variant
    Creutzfeldt-Jakob Disease (vCJD), the human form of mad
    cow disease[2],[3].
    - The Medical and Scientific Advisory Council (MASAC)
    of the National Hemophilia Foundation has issued a
    formal recommendation (#141) advising that "all efforts
    should be made to remove human albumin from recombinant
    factor VIII products," and "increased efforts should be
    made to eliminate human and bovine proteins from the
    manufacturing process of recombinant products."[4]
    - In 2003, the United Kingdom Haemophilia Centre
    Doctors' Organisation issued a guideline stating: "To
    reduce the chance of infection by exogenous viruses in
    a recombinant concentrate, consideration should be
    given to choosing one, where available and licensed,
    that is manufactured with the least addition of human
    or animal protein." (Reference: Haemophilia. 2003;
    9:1-23.)
    Demonstrated Safety Profile/Clinical Trials
    - Phase II-III clinical trials evaluated the safety,
    immunogenicity and efficacy of ADVATE in the treatment
    and prevention of bleeding in previously treated
    haemophilia A patients in a variety of clinical
    settings. Data demonstrate that ADVATE has equivalent
    pharmacokinetic properties to RECOMBINATE, the first
    non-plasma derived recombinant factor VIII therapy, and
    is effective in controlling bleeding episodes in
    patients with severe haemophilia A.
    - Side effects with the use of ADVATE are uncommon,
    with no serious adverse events related to treatment
    with ADVATE reported to date. Non-serious, moderate or
    mild adverse events related to ADVATE include: a
    strange taste, itching at the infusion site, dizziness,
    headaches, catheter-related infections, chills, hot
    flushes, diarrhea, lower limb edema, sweating, nausea,
    pain in the upper abdomen or lower chest, prolonged
    bleeding after post-operative drain removal, decreased
    red blood cell count, joint swelling and shortness of
    breath. Non-serious, but severe related adverse events
    include: fever, headache and decreased coagulation
    factor VIII levels.
    Benefits of ADVATE
    - The innovative technology used to process ADVATE
    eliminates the potential pathogen risk associated with
    the use of animal- and human-derived plasma protein
    additives.
    - ADVATE is convenient for patients to use because it
    is available in extra-high potency (1500 IU/vial) so
    there may be fewer vials to reconstitute compared to
    RECOMBINATE, with a smaller infusion volume (5 mL
    solvent), which could lead to shorter infusion times
    for patients. ADVATE comes packaged with a 10mL
    syringe, butterfly, 2 alcohol swabs, 2 plasters, a
    device for reconstitution and a patient-friendly
    package insert.
    - Low rates of inhibitor development have been observed
    in previously treated patients in ADVATE clinical
    trials.
    - Baxter has the capacity to ensure supplies of ADVATE
    based on current and anticipated future needs. ADVATE
    is processed by Baxter in its dedicated, state-of-the
    art, recombinant protein processing facility in
    Neuchâtel, Switzerland.
Please see full prescribing information for further information.
Baxter, ADVATE and RECOMBINATE are trademarks of Baxter
International Inc. and its affiliates.
[1] Kasper CK. Concentrate safety and efficacy. Haemophilia, 2002,
8, p. 161.
[2] Update on West Nile Virus and Blood and Organ Donations,
National Hemophilia Foundation, Medical Advisory #393.
[3] Farrugia A. Evolving perspectives in product safety for
haemophilia. Haemophilia (2002), 8, pp. 236-243.
[4] MASAC Recommendation #141 Treatment of hemophilia and other
bleeding disorders (revised March 2003). MASAC Treatment
Recommendations, National Hemophilia Foundation, 2002

Contact:

U.S. Media contact: Cindy Resman, +1(847)-948-2815, Europe Media
contacts: Hans Vanavermaete, Baxter, +32-2-650-17-03, Inge Boets,
Porter Novelli, +32-2-413-03-40, Investor contact: Mary Kay Ladone,
+1(847)-948-3371