Baxter International Inc. (BAX)

[mlkrborn]

Baxter presents Phase III HyQ efficacy and tolerability data at American College of Allergy, asthma & immunology meeting (BAX) 53.71 : The majority of patients infused their HyQ dose in a single site and nearly 98 percent of infusions were completed without changes in infusion rate due to tolerability. The most common local adverse reactions were discomfort/pain, erythema, swelling/edema and pruritus. Systemic adverse events occurred in 8.3 percent of HyQ infusions compared to 25 percent of IGIV infusions in the control arm. In HyQ treated patients, serious validated bacterial infections occurred at an annualized rate of 0.025, which is lower than the threshold set by the FDA of less than 1.0 annually, and the annual rate of all infections was 2.97. Further, HyQ was bioequivalent to IGIV at 108 percent of the IV dose at 3- or 4-week intervals. HyQ provided a lower peak IG concentration compared to IGIV, similar to weekly IGSC, with trough levels similar to every three or four-week IGIV treatment. Baxter has submitted applications for marketing approval of HyQ in the United States and in Europe, both of which have been accepted for review by the regulatory authorities.