Kedrion Biopharma has announced that it has secured FDA approval for QIVIGY, intended for adult patients suffering from primary humoral immunodeficiency (PI). This group of disorders weakens the immune system’s ability to protect the body from infection. Developed entirely in Kedrion’s research laboratories and manufactured through its integrated facilities in the U.S. and Italy, QIVIGY aims to fill gaps in treatment options for individuals with PI.
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Ugo Di Francesco, Kedrion’s Chief Executive Officer, reflected on the milestone by highlighting the years of vision, planning, and relentless dedication involved in bringing QIVIGY to life. He emphasized that the approval validates not just scientific and operational prowess, but also the company’s patient‑centred mission and ability to deliver. Bob Rossilli, Global Chief Commercial Officer and U.S. General Manager, added that 2025 marks a transformational year for Kedrion: QIVIGY is its first product launch under the rebranded identity, signaling a sharper focus, stronger connectivity, and deeper commitment to patient outcomes.
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The clinical evaluation of QIVIGY spanned 12 months in adult PI patients and successfully met its primary endpoint: no occurrences of acute serious bacterial infections. Secondary outcomes showed a low rate of other infections, no hospitalizations tied to infections, and minimal interference with daily life. The most commonly reported adverse events were headache, infusion reactions, fatigue, nausea, and positive direct Coombs test results.
Kedrion underscored the significant real-world impact: fewer serious bacterial infections means patients with primary immunodeficiency can live with less disruption, reducing time away from school or work. PI covers over 550 rare, lifelong disorders in which essential immune components are missing or impaired, leaving sufferers prone to infections, autoimmune issues, and other complications. While up to 500,000 people in the U.S. are estimated to live with PI, its true prevalence may be markedly higher due to frequent underdiagnosis.
Alongside QIVIGY’s approval, Kedrion laid out its long-term strategy in the U.S. and globally. The company will expand its U.S. plasma collection infrastructure, committing over $260 million to build more than 40 new collection centers. To support growing demand, Kedrion will also invest in capacity expansion at its Melville, New York manufacturing facility (over $60 million), enhance its IT systems and clinical trial programs (more than $80 million), and allocate over $15 million toward the U.S. launch of QIVIGY. The company intends to progressively roll out QIVIGY in global markets, leveraging its supply chain and distribution network to ensure access worldwide.
By achieving this approval and backing it with robust investment, Kedrion is reinforcing its evolution from manufacturer to innovator in rare disease therapeutics, signaling that QIVIGY is only the beginning of the company’s journey toward broader impact in immunological and neurological care.
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