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News
A new weekly self-injectable treatment for generalized myasthenia gravis (gMG) is one step closer to EU approval. Europe's drug advisory committee has recommended marketing authorization for Klygefa (gefurulimab), an add-on therapy for AChR antibody-positive adults. A phase 3 trial showed meaningful symptom improvements within just one week of starting treatment.
Europe's drug advisory body has given a thumbs-up to Klygefa (gefurulimab, Alexion/AstraZeneca) as a weekly add-on treatment for adults with generalized myasthenia gravis (gMG) who test positive for anti-acetylcholine receptor (AChR) antibodies — a group that makes up roughly 85% of all gMG patients. The recommendation from the EMA's Committee for Medicinal Products for Human Use (CHMP) now heads to the European Commission, which typically issues a final binding decision within about two months.
gMG is a rare autoimmune disease where antibodies attack the neuromuscular junction, causing debilitating muscle weakness, fatigue, and in severe cases, respiratory failure. Klygefa works by blocking complement protein C5, halting the inflammatory cascade that drives nerve-muscle communication breakdown. Its binding to serum albumin extends its half-life, making once-weekly subcutaneous dosing possible — a convenience that could meaningfully improve adherence and quality of life.
By the Numbers
Why it matters: For patients managing a condition that can be unpredictable and life-altering, a weekly at-home injection that works fast and sustains benefits is a significant step forward. If the European Commission grants approval, Klygefa would offer a new, convenient option in a space where treatment choices remain limited.
