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News
The FDA has granted orphan drug designation to Qivigy, an intravenous immune globulin, as a potential treatment for stiff person syndrome (SPS) — a rare, debilitating condition with no approved therapies targeting its root cause. Maker Kedrion Biopharma is now running a Phase 3 trial to test Qivigy's safety and efficacy against placebo, with results expected to shed light on whether it can meaningfully reduce muscle rigidity and spasms in SPS patients.
A rare disease finally gets some regulatory attention. The FDA has granted orphan drug designation to Qivigy (immune globulin intravenous, human-kthm), a 10% intravenous immunoglobulin (IVIg) therapy, as a potential treatment for stiff person syndrome (SPS). Developed by Kedrion Biopharma, Qivigy is already approved in the U.S. for primary humoral immunodeficiency — and now it's being studied for SPS, a rare neurological disorder that causes progressive muscle rigidity, debilitating spasms, frequent falls, and severe functional decline.
Currently, no U.S.-approved treatments address the underlying neuro-immunological cause of SPS. Existing options only manage symptoms. The orphan designation is a meaningful step toward changing that, as it incentivizes development of therapies for rare diseases affecting fewer than 200,000 Americans.
By the Numbers:
Why it matters: For SPS patients who often endure years of diagnostic delays and worsening disability, Qivigy represents a promising first step toward a targeted, immune-modulating therapy — one that could restore functional independence rather than just masking symptoms.
