UK grants promising innovative medicine status to CIDP drug

Therapy for autoimmune disorder shows potential

Argenx’s investigational therapy, subcutaneous efgartigimod alfa, has been granted Promising Innovative Medicine (PIM) status by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for treating chronic inflammatory demyelinating polyneuropathy (CIDP).

This designation signals its potential for the UK’s Early Access to Medicines Scheme (EAMS).

David Knechtel, General Manager of argenx UK & Ireland, said, “We welcome the MHRA’s recognition of efgartigimod alfa’s potential to address the significant unmet need in CIDP.”

CIDP is an autoimmune disorder of the peripheral nervous system, causing severe disability through muscle weakness and sensory issues. It affects around 650 people annually in the UK, often leading to long-term disability.

Current treatments fail many patients, leaving them with ongoing neurological problems.

Efgartigimod alfa is a human antibody fragment designed to block a receptor involved in the autoimmune response, reducing harmful antibodies attacking nerve cells.

Already used for treating generalised myasthenia gravis (gMG), efgartigimod alfa now shows promise for CIDP. Knechtel highlighted the urgent need for effective alternatives given the limitations of current therapies.

The new designation marks the second PIM status for efgartigimod, previously recognised for gMG treatment. CIDP patients and healthcare providers alike hope this innovative approach will soon provide relief where existing options fall short.

With ongoing research and potential EAMS inclusion, argenx aims to bring this therapy to those in need swiftly. The investigation into efgartigimod alfa’s efficacy in CIDP continues, offering hope for improved patient outcomes and quality of life.

This recognition from the MHRA underscores the therapy’s promise and the need for continued innovation in treating severe autoimmune diseases.