Baxter is having another go at seeking US approval for its HyQvia replacement therapy for adults with primary and secondary immunodeficiencies after the drug was rejected by the Food and Drug Administration (FDA) last year.
HyQvia – which uses delivery technology developed by Halozyme Therapeutics – is a combination of human normal immunoglobulin (IG) and recombinant human hyaluronidase which can be delivered by subcutaneous injection every three to four weeks, unlike other IG products which need to be given intravenously.
The product has already been approved in Europe for primary and secondary immunodeficiencies and also for the treatment of patients with myeloma or chronic lymphocytic leukaemia (CLL) who experience severe secondary hypogammaglobulinaemia and recurrent infections.
The FDA had asked for additional information on HyQvia before it could consider approval, including preclinical data on the possible effects of non-neutralising antibodies on reproduction, development and fertility.
Now, Baxter says it has filed everything the regulator asked for and hopes that HyQvia will be approved within the next six months.
“We believe that if approved, HyQvia may become a valuable option for patients with immune deficiency,” said Ludwig Hantson, president of Baxter’s BioScience business. “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,” he added.
Baxter already sells an intravenous immunoglobulin product called Gammagard Liquid that accounts for a piece of its biotherapeutics sales, which were around $1.55bn in the first nine months of 2013. The global market for intravenous immunoglobulin therapy is around $6bn a year, and, with a quarter of a million possible recipients in the US alone, analysts have suggested that the increased convenience of HyqVia could allow it to capture sales of $1.5bn at peak.
Meanwhile, for Halozyme the news of the re-filing in the US comes after a series of positive developments, including the first launch of HyQvia in Germany and the EU approval of Roche’s subcutaneous formulation of breast cancer blockbuster Herceptin (trastuzumab), a product which also makes use of its delivery technology.