Baxter's once-monthly Hyqvia for immune disorders wins FDA approval
- For most patients with primary immondeficiency (PI), multiple treatments are administered once or twice per week via infusion in a doctor’s office.
- Baxter and Halozyme's Hyqvia is the first subcutaneous immunoglobulin (IG) for PI patients, and it requires just one infusion up to once per month at one injection site.
- Hyqvia was initially rejected by the FDA in 2012. It was approved in the EU in 2013.
PI diseases are comprised of more than 200 different rare and chronic disorders that are caused by genetic defects that affect the immune system. Traditionally, PI patients have been treated with IG frequently and at different injection sites. Hyqvia's approval is a breakthrough for these patients, providing additional treatment options, as well as improved quality of life.
Baxter's global antibody therapy sales already stand at about $1.4 billion. Halozyme will receive a 5% royalty on Hyqvia sales. Both stocks opened down on Monday.
- Pharma Times FDA gives green light to Baxter's Hyqvia