Baxter files amended BLA to FDA for HyQvia for primary immunodeficiency

USA-based Baxter International (NYSE: BAX) has completed submission of an amended biologics license application (BLA) to the US Food and Drug Administration to re-initiate the review process for approval of HyQvia (immune globulin infusion 10% [human] with recombinant human hyaluronidase) facilitated subcutaneous infusion for the treatment of adult patients with primary immunodeficiency (PI).

Baxter and fellow USA-based partner Halozyme Therapeutics (Nasdaq: HALO) submitted additional preclinical data that was requested from the FDA in 2012, and expect a six-month review period. Halozyme’s shares rose as much as 3.9% to $15.33 in mid-morning trading, while Baxter gained 1% to $69.16.

Could provide valuable option for patients