Baxter International has filed an amended biologics license application (BLA) to the US Food and Drug Administration (FDA) to re-start the review process for approval of HyQvia facilitated subcutaneous infusion for the treatment of adult patients with primary immunodeficiency (PI).
HyQvia is a combination of human normal immunoglobulin (IG 10%) and recombinant human hyaluronidase (licensed from Halozyme).
The company and its partner Halozyme Therapeutics have submitted additional preclinical data as requested by the FDA, and hope the HyQvia review process to be completed in the next six months.
If approved, HyQvia could become an option for patients with immune deficiency as it allows for the delivery of a full dose of immunoglobulin often in a single site every three to four weeks, in the patient’s home.
The original BLA filing was based on results from a prospective, open-label, non-controlled multi-centre Phase III clinical study, which assessed the safety and effectiveness of HyQvia in the prevention of acute serious bacterial infections, rate of adverse reactions and the pharmacokinetic parameters compared to immunoglobulin administered intravenously.
In the tolerability evaluation of HyQvia, the most frequently reported adverse reactions for patients who received HyQvia were local infusion site reactions such as pain or discomfort, redness, swelling, and itching, as well as headache, nausea, fatigue and fever.
In several European countries, HyQvia was approved and launched in the second half of 2013.
The IG offers the therapeutic effect, while the recombinant human hyaluronidase facilitates the dispersion and absorption of the IG administered subcutaneously, increasing its bioavailability.
The company said that IG is a 10% solution that is prepared from human plasma consisting of at least 98% IgG, which contains a broad spectrum of antibodies.
The product is indicated in Europe as replacement therapy in adults (> 18 years) with primary immunodeficiency syndromes and in myeloma or chronic lymphocytic leukaemia (CLL) with severe secondary hypogammaglobulinaemia and recurrent infections.