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Kedrion Biopharma celebrates FDA approval of Qivigy, enhancing treatment options for primary immunodeficiency while committing to significant U.S. investments.
Following Qivigy’s approval, Kedrion confirms its plans to increase its U.S.-based investments throughout its global operations.
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Kedrion Biopharma announced it has received FDA approval for Qivigy immune globulin intravenous (human)-kthm 10% liquid.1 Qivigy is indicated for the treatment of adults diagnosed with primary humoral immunodeficiency (PI).
Developed in Kedrion’s research labs, Qivigy is produced exclusively by Kedrion through its global network of manufacturing facilities in the U.S. and Italy. Qivigy’s safety and efficiency were evaluated during a 12-month clinical study in adults with PI, with the therapy achieving its primary endpoint with no acute serious bacterial infections reported.1 Secondary outcomes demonstrated a low rate of other infections, with no infection-related hospitalizations and minimal disruption to daily activities.
Ugo Di Francesco, Kedrion's chief executive officer, touched on Qivigy’s approval, saying, “Seeing Qivigy receive FDA approval is a deeply meaningful moment for all of us at Kedrion. This achievement is the result of years of vision, planning, and relentless dedication from countless employees, both current and previous." Di Francesco continued, saying, "It reflects not only our scientific and operational capabilities, but also the heart and purpose that drive our mission to serve patients. Today we celebrate two success stories, one in the delivery of a product that helps improve patient care, and another that defines us as an organization demonstrating our ability to deliver while also illuminating the path ahead."
Qivigy’s approval adds an additional IVIG treatment to Kedrion’s broad offering of treatments for patients and healthcare providers that are designed to meet unique needs of the patients. Oivigy also holds potential to be developed from concept and brought to commercialization exclusively by Kedrion, with Qivigy joining Kedrion’s global portfolio of 38 products spanning various therapeutic areas.1 This achievement displays Kedrion’s depth and capabilities as a manufacturer, researcher, developer, and brand innovator.1
Kedrion displayed its commitment to its global and U.S. infrastructure, along with lifecycle management for QIVIGY which includes ongoing research and development activities aiming to identifying new opportunities for broader patient populations suffering from rare immunological and neurological conditions. Kedrion additionally showed its commitment through its long-term investments in manufacturing facilities and its capacity expansion aimed to support growth.
Kedrion's financial commitment to Qivigy encompasses every phase of its production, starting from increasing its U.S. plasma collection network by investing over $260 million in developing over 40 new U.S. collection centers across the next several years.1 As plasma collection efforts accelerate, manufacturing capacity must keep pace. To support the growth, Kedrion plans to invest upwards of $60 million in capacity expansion projects at its Melville, New York manufacturing facility, while simultaneously expanding its global capacity, along with investing an additional $80 million to be spent on IT infrastructure and clinical studies as well as over $15 million to launch QIVIGY in the U.S.1
"Kedrion's commitment to global growth with a specific focus on the U.S. is impressive and doesn't stop with QIVIGY. Kedrion will continue to grow its new product development programs, with significant capex investments over the next few years. Kedrion's strategic direction is to continue expanding in the United States to meet the growing demand for rare disease therapies," said Bob Rossilli, global chief commercial officer and U.S. general manager.
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