As reported by The Pharma Letter, the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted a new indication for argenx’s Vyvgart (efgartigimod alfa), expanding the therapy’s use to adults with progressive or relapsing active chronic inflammatory demyelinating polyneuropathy (CIDP). The decision, delivered through the agency’s reliance review pathway, boosted shares of the Dutch immunology company by 2%, reaching €742.20.
The newly approved subcutaneous formulation of efgartigimod alfa is indicated for patients who have previously been treated with corticosteroids or immunoglobulins. The therapy also carries an orphan designation in the UK, reflecting its potential to meet significant unmet medical needs associated with CIDP—a rare, debilitating neurological disorder marked by progressive weakness and impaired sensory function.
MHRA’s authorization arrives two months ahead of expectations and follows the European Commission’s approval of the same indication in June. The therapy had earlier received a Promising Innovative Medicine (PIM) designation from the MHRA in November 2024, highlighting regulatory recognition of the importance of advancing new therapeutic options for CIDP.
With this latest approval, argenx continues to broaden the clinical reach of its FcRn‑targeting antibody fragment platform as global demand grows for more effective treatments addressing autoimmune neuromuscular diseases.
