European Medicines Agency Approves Once Every Two Weeks Dosing Option For
Hizentra®▼ (Human Normal Immunoglobulin, SCIg)
Data Supports Less Frequent Dosing in Patients with Primary and Secondary
HAYWARDS HEATH, England -- December 5, 2013
CSL Behring UK Ltd announced today that the European Medicines Agency (EMA)
has expanded the administration options for Hizentra^®▼, human normal
immunoglobulin, SCIg, 20% liquid, to include dosing once every two weeks
Hizentra initially received EMA approval in 2011 as a 20%, once weekly SCIg
replacement therapy for adults and children with PID to help treat existing or
chronic infections and prevent new infections from occurring. Hizentra can
also be stored at room temperature for up to 30 months meaning it is ready to
Dosing once every two weeks with Hizentra can offer adult and paediatric
patients consistent levels of IgG similar to weekly infusions, while providing
patients with the option of infusing less frequently.
The data to support dosing once every two weeks with Hizentra is based on the
principles of pharmacometrics and pharmacokinetic modelling that included
3,800 data points for U.S. and EU clinical trials and 300 simulated trials.^1
“To provide the best care to patients, therapy needs to be individualised to
meet particular needs,” said Dr Alison Jones, Consultant Paediatric
Immunologist, Great Ormond Street Hospital for Children NHS Foundation Trust.
“We now have the data to confirm that fortnightly administration provides
equivalent protection as compared to weekly administration. This will give
patients and their carers increased confidence to use flexible dosing.”
“CSL Behring has long been at the forefront of developing immunoglobulin
replacement therapy advances that provide clinicians with the ability to
individualise treatments to meet their patients’ lifestyle needs and
preferences,” said Edward Owens, General Manager, UK & Ireland, CSL Behring.
“We are extremely pleased to now offer patients with primary and secondary
immunodeficiencies the option of receiving Hizentra weekly or fortnightly.
This new dosing option underscores CSL Behring’s commitment to meeting the
individual needs of patients who rely on our therapies.”
Hizentra is indicated for:
*Replacement therapy in adults and children in primary immunodeficiency
(PID) syndromes such as:
*congenital agammaglobulinaemia and hypogammaglobulinaemia
*common variable immunodeficiency
*severe combined immunodeficiency
*IgG subclass deficiencies with recurrent infections.
*Replacement therapy in myeloma or chronic lymphocytic leukaemia with
severe secondary hypogammaglobulinaemia and recurrent infections.
About Primary Immunodeficiency Disease (PID)* and Secondary Immunodeficiency
PID is not a single condition but a group of more than 150^2 disorders that
are caused by an absent or dysfunctional immune system.
People with PID are more susceptible to recurrent and serious infections
caused by everyday pathogens such as bacteria, fungi and viruses. Depending on
the type of infection, it may affect the lungs causing chest infections,
sinuses causing sinusitis or the intestines causing diarrhoea. They are also
more likely to get autoimmune diseases, where the immune system attacks an
individual's own cells or tissue.
Individuals with PID are also less able to fight infections and may not
respond to the usual treatments. Infections may keep returning and as a
result, patients may require multiple rounds of antibiotics or hospitalisation
If an individual with PID suffers from repeated infections it can lead to
organ damage which over time can become life threatening.
Secondary immunodeficiency (SID), also known as acquired immunodeficiency,
occurs when the immune system is compromised due to an environmental factor.
Examples include HIV, burns, malnutrition, aging and particular medications
(e.g. chemotherapy, disease-modifying antirheumatic drugs, immunosuppressive
drugs after organ transplants, glucocorticoids etc.).
*Information from www.pidinfo.co.uk
- ends -
Important safety information for Hizentra
Adverse reactions such as local reactions at infusion sites, chills, headache,
fever, vomiting, allergic reactions, nausea, arthralgia, low blood pressure
and moderate low back pain may occur occasionally.
Rarely human normal immunoglobulins may cause a sudden fall in blood pressure
and in isolated cases, anaphylactic shock, even when the patient has shown no
hypersensitivity to previous administration.
Please see the Summary of Product Characteristics for further information and
a list of rare reactions.
About CSL Behring
CSL Behring is a leader in the plasma protein therapeutics industry. Committed
to improving the quality of life for people with rare and serious diseases,
the company manufactures and markets a range of plasma-derived and recombinant
CSL Behring therapies are used globally to treat coagulation disorders
including haemophilia and von Willebrand disease, primary immune deficiencies,
hereditary angioedema and neurological disorders. The company’s products are
also used in organ transplantation, burn treatment and to prevent haemolytic
diseases in the newborn. CSL Behring operates one of the world’s largest
plasma collection networks, CSL Plasma. CSL Behring is a subsidiary of CSL
Limited (ASX:CSL), a biopharmaceutical company headquartered in Melbourne,
Australia. For more information, visit http://www.cslbehring.co.uk.
^1. CSL Behring. Data on File. November 2013
^2. Geha R, Notarangelo L, Casanova JL, Conley ME, Chapel ME, Fischer A,
Hammerstrom L, Nonoyama S, Ochs H, Puck J, Roifman C, Seger R, Wedgwood J.
Primary Immunodeficiency Diseases: An Update from the International Union of
Immunological Societies Primary Immunodeficiency Diseases Classification
Committee Meeting. Journal of Allergy and Clinical Immunology 2007;
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