Launch
Injectable Nanobody Wins FDA Approval for Myasthenia Gravis
The Brief
- The FDA approved injectable gefurulimab (brand name Klygefa) for generalized myasthenia gravis in adults who are anti-acetylcholine receptor (AChR) antibody positive.
- Gefurulimab is a dual-binding nanobody that blocks activation of complement component 5 (C5).
- MedPage Today reported the approval on 2026-11-13.
Why it matters
It adds a new injectable C5-blocking treatment option for a subset of adults with generalized myasthenia gravis, a neuromuscular autoimmune disease.
Who’s affected
- neurologists and clinicians treating generalized myasthenia gravis
- adults with anti-AChR antibody-positive generalized myasthenia gravis
- researchers following complement-targeted therapies
- #myasthenia gravis
- #nanobody
- #complement inhibitor
- #fda approval
- #neurology
- #drug approval
(MedPage Today) -- The FDA on Friday approved injectable gefurulimab (Klygefa), a dual-binding nanobody that blocks complement component 5 (C5) activation, to treat generalized myasthenia gravis in adults who are anti-acetylcholine receptor (AChR...
Timeline
FDA approved gefurulimab (Klygefa) for generalized myasthenia gravis in anti-AChR antibody-positive adults
MedPageToday.com - medical news for physicians
Injectable Nanobody Wins FDA Approval for Myasthenia Gravis