EMA expands administration options for Hizentra

CSL BehringDec 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 (fortnightly).

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 use.

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.

"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.