Baxalta Inc. announced that it has submitted an application to the U.S. Food and Drug Administration (FDA) for approval of an investigational 20 percent concentration immunoglobulin subcutaneous treatment.
Baxalta is focused on delivering innovative new solution to support people with primary immunodeficiencies (PI), a group of disorders where the body’s immune system is missing or does not function properly.
“We look forward to rapidly introducing this treatment to people with primary immunodeficiencies in the U.S. upon FDA approval," a team from Baxalta said. "The treatment is also under review in Europe, with an expected decision from the European regulatory bodies by mid-2016.
“The clinical data supporting IGSC 20 percent are important to recognize the attributes of the treatment. In the study, IGSC 20 percent met the primary endpoint as measured by the rate of acute serious bacterial infections. Nearly all infusions were completed without a reduction, interruption or discontinuation for tolerability reasons and most were administered using less than or equal to two infusion sites.”
The company is confident the treatment will shed a light on a new treatment for people with PI if it is approved. They will continue to advance patient-focused innovation to find new solutions for the PI community.
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