Baxalta submits application for immunoglobulin subcutaneous treatment

Baxalta Incorporated has 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.

The treatment is for patients with primary immunodeficiencies, a group of disorders in which part of the body's immune system is missing or doesn’t function properly.

“Our IGSC, 20 percent investigational treatment was developed to give patients more IG treatment options that meet their individual needs,” John Orloff, executive vice president, head of research & development and chief scientific officer at Baxalta, said. “Regulatory reviews are now underway in both Europe and the U.S., and we look forward to introducing this new IG treatment option as we continue to build on our leadership in the PI community.”

The filing in the U.S. is based on positive results from a Phase 2/3 study of IGSC, 20 percent in North American patients at least two years old with PI. In the study, IGSC, 20 percent met the primary endpoint as measured by the rate of acute serious bacterial infections.

Baxalta develops, manufactures and commercializes therapies for orphan diseases and underserved conditions in hematology, oncology and immunology. Baxalta’s broad and diverse pipeline includes biologics with novel mechanisms and advanced technology platforms such as gene therapy.