The European Commission has given the green light to Baxter International and Halozyme Therapeutics' HyQvia as replacement therapy for adults with primary and secondary immunodeficiencies.
HyQvia is a combination of human normal immunoglobulin and recombinant human hyaluronidase, which facilitates the dispersion and absorption of the IGSC. The treatment, which is administered in a single subcutaneous site every three to four weeks, is also approved as replacement therapy in adults with myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinemia and recurrent infections.
Ludwig Hantson, head of Baxter's BioScience business, said the thumbs-up "represents an important advance for patients who are managing a chronic disease as HyQvia combines key benefits of intravenous and subcutaneous administration into one product". He added that the firm will introduce the therapy in the coming weeks in key European markets.
Rejected in USA last year
Getting approval in Europe may help Baxter in its dealings with the US Food and Drug Administration which issued a complete response letter for the product, known across the Atlantic as HyQ, in August.
The agency asked for additional preclinical data and expressed concern about the possible effects of non-neutralising antibodies on reproduction, development and fertility.