Today, Halozyme Therapeutics and Baxter International announced that Baxter has been granted a Positive Opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (EMA CHMP) for the use of HyQvia (solution for subcutaneous use) as replacement therapy for adult patients with primary and secondary immunodeficiencies. HyQvia is a combination of human normal immunoglobulin (IGSC, 10%) and recombinant human hyaluronidase, which facilitates the dispersion and absorption of the IGSC.
Receiving this recommendation from the EMA CHMP supports the combined efforts of Halozyme and Baxter to improve overall patient care quality. Once approved by the European commission, the therapy will give patients the option to administer their therapy at home every three to four weeks via a single subcutaneous site. This will potentially result in lower systemic adverse reactions as compared with intravenous treatments.
“We look forward to introducing HyQvia as a new patient-friendly therapeutic option for immunodeficient patients,” said Ludwig Hantson, Ph.D., president of Baxter’s BioScience business.
This application was based on the results of a Phase III, prospective, open-label, non-controlled design clinical trial to evaluate the safety and efficacy of HyQvia in preventing acute serious bacterial infections, as well as the pharmacokinetic parameters compared with intravenously administered immunoglobulin. The study’s objective was to infuse a three-week or four-week dose of the therapy in a single subcutaneous site. In the study, the acute serious bacterial infection rate was 0.025 per patient per year, which is below the required efficacy threshold of 1.0 (serious bacterial infections per patient per year). In HyQvia’s tolerability assessment, the adverse reactions most frequently reported were infusion site reactions, occurring in 20% of infusions; headache, occurring in 3% of infusions; fatigue, occurring in 1% of infusions; and pyrexia, or fever, occurring in 1% of infusions.
Baxter plans to launch HyQvia in selected countries within the European Union later this year, after marketing authorization has been received from the European Commission.
“Recognizing that the path to approval for any biologic is a long journey, I would like to thank and congratulate the teams at Halozyme and Baxter who have worked tirelessly to advance this therapeutic option for patients,” said Halozyme Therapeutics President and CEO Gregory I. Frost, Ph.D.
For more information, visit www.halozyme.com
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