Kedrion Biopharma has scored an FDA approval for Qivigy for adults with primary humoral immunodeficiency (PI), a group of disorders that prevent the immune system from operating effectively.
As an intravenous immunoglobulin (IVIG) therapy, Qivigy provides patients with antibodies that are intended to help them ward off infections.
Along with the approval, the Italian plasma collection specialist was quick to point out in a release that it plans to increase its investments in the United States. To support the production of Qivigy, Kedrion announced plans to invest more than $260 million in expanding its U.S. network with over 40 new plasma collection centers.
The company also said it will invest more than $60 million to expand capacity at its manufacturing facility in Melville, New York.
Other related spending plans include $80 million for IT infrastructure and clinical trials, along with $15 million to launch Qivigy in the U.S., which the company anticipates will happen early next year.
“Kedrion's strategic direction is to continue expanding in the United States to meet the growing demand for rare disease therapies,” Bob Rossilli, the company’s chief commercial officer and U.S. general manager, said in a statement.
Qivigy was approved based on results from a trial in which 47 patients were infused every three or four weeks for 12 months. The study accomplished its primary endpoint, with investigators recording no acute bacterial infections in the treated patients. Secondarily, there was a low annual rate—2.1 infections per patient on average—of other infections, with none resulting in hospitalization.
Common adverse events included headache, infusion-related reactions, fatigue and nausea.
“For individuals living with primary immunodeficiency, the absence of serious bacterial infections means fewer disruptions to daily life, which in turn, means less time away from school and work due to hospitalizations,” Nisha Jain, Kedrion’s VP of global clinical development, said in a release.
Roughly 500,000 in the U.S. are living with PI, with the number likely higher due to underdiagnosis, according to the company. The grouping includes more than 550 rare disorders in which people are susceptible to recurrent infections and autoimmune complications.
As opposed to the 38 other products in Kedrion’s global portfolio, Qivigy was developed from concept by the 24-year-old company, demonstrating its “growing capabilities from manufacturer to researcher, developer and branded innovator,” it wrote.
The company reported 2024 sales of 1.58 billion euros ($1.7 billion), a 10% increase from 2023. Kedrion was established as Kedplasma GmbH in 2001 before a rebranding in 2020.