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 to treat adult patients with primary immunodeficiency (PI).
HyQvia is a combination of human immune globulin (IG) and recombinant human hyaluronidase.
Baxter and its partner Halozyme Therapeutics have submitted additional preclinical data that was requested from the FDA, and hope that HyQvia will be approved within the next six months.
If approved, HyQvia may become a valuable 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 comfort of a patient's home, according to Baxter.
The original BLA was based on results from a prospective, open-label, non-controlled multi-center Phase III clinical trial, which evaluated 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 and it includes human normal immunoglobulin (IG 10%) and recombinant human hyaluronidase (licensed from Halozyme).
The IG offers the therapeutic effect, while the recombinant human hyaluronidase facilitates the dispersion and absorption of the IG administered subcutaneously, increasing its bioavailability.
According to the company, IG is a 10% solution that is prepared from human plasma consisting of at least 98% IgG, which contains a broad spectrum of antibodies.
In Europe, HyQvia is indicated 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.
