AstraZeneca’s Klygefa received a positive CHMP recommendation for EU use in adults with anti-AChR-positive generalised myasthenia gravis, based on PREVAIL results. If approved, the treatment would be the EU’s first and only dual-binding nanobody C5 inhibitor for this population, with once-weekly self-administration.

Key Highlights

  • Klygefa has received a positive recommendation for European Union approval in adults with anti-acetylcholine receptor antibody-positive generalised myasthenia gravis.
  • Improvement with Klygefa appeared as early as week one and continued through the study period.
  • Positive recommendation for European Union approval in adults with anti-acetylcholine receptor antibody-positive generalised myasthenia gravis
  • Proposed as an add-on to standard therapy

ASTRAZENECA PLC (NYSE: AZN) is a Pharmaceuticals: Major company. Klygefa (gefurulimab) has received a positive recommendation for European Union approval in adults with anti-acetylcholine receptor antibody-positive generalised myasthenia gravis. The proposed use is as an add-on to standard therapy.

PREVAIL Results Support Recommendation

Improvement appeared as early as week one and continued through the study period. Klygefa was generally well tolerated. Its safety profile was consistent with earlier generalised myasthenia gravis studies of the C5 inhibitors eculizumab and ravulizumab.

Further Regulatory Steps

The recommended treatment is a complement C5 inhibitor designed for subcutaneous use. Its dual-binding structure includes binding to serum albumin, which supports an extended half-life. The PREVAIL open-label extension remains ongoing to evaluate safety and efficacy.