The US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Kedrion’s Immune globulin Intravenous human 10% solution (tradename QIVIGY®) for the treatment of Stiff Person Syndrome (SPS), a rare and often disabling neurological disorder.
Stiff Person Syndrome is an ultra-rare immune-mediated disorder characterized by progressive muscle rigidity and painful, unpredictable muscle spasms that can significantly affect mobility and quality of life. Despite the availability of symptomatic treatments, people living with SPS continue to face substantial unmet medical needs.
This designation marks an important milestone for Kedrion and reinforces our commitment to developing new possibilities for people living with rare and ultra-rare conditions.
Nisha Jain, Vice President, Global Clinical Development and Strategy at Kedrion, said: “Orphan Drug Designation is an important regulatory and clinical milestone as we explore the role of QIVIGY® to address the critical unmet need for people living with Stiff Person Syndrome. This designation reinforces Kedrion’s commitment to advancing plasma-derived therapies for rare and ultra-rare disorders and expanding treatment opportunities for underserved patient communities.”
Safety and efficacy of QIVIGY in Stiff Person Syndrome are currently being evaluated in a clinical study.