Argenx receives positive CHMP opinion for CIDP treatment

VYVGART could be the first CIDP drug with a novel mechanism in 30 years

Argenx has announced that the Committee for Medicinal Products for Human Use (CHMP) has recommended European Commission (EC) approval for VYVGART (efgartigimod alfa) as a subcutaneous treatment for adults with progressive or relapsing chronic inflammatory demyelinating polyneuropathy (CIDP).

The recommendation is based on data from the ADHERE trial, the largest CIDP clinical study to date. The trial showed that 66.5% of patients treated with VYVGART demonstrated improvements in mobility, function and strength. The drug met its primary endpoint, with a 61% reduction in relapse risk compared to placebo.

VYVGART is the first IgG Fc-antibody fragment targeting CIDP and marks the first CIDP treatment with a novel mechanism of action in more than 30 years, if approved. The treatment is designed for patients after prior corticosteroid or immunoglobulin therapy and will be available as a vial or prefilled syringe, administered weekly and later adjusted to every other week.

Argenx chief medical officer Luc Truyen said: “The positive CHMP opinion for VYVGART brings us one step closer to providing patients across Europe with a transformational new treatment option that provides meaningful functional improvement.”

The European Patient Organisation for Dysimmune and Inflammatory Neuropathies (EPODIN) welcomed the news. Jean-Philippe Plançon, EPODIN president, said: “There are still considerable unmet medical needs in the management of CIDP, and the CHMP’s recommendation brings renewed hope for improved treatment options and quality of life.”

The CHMP opinion now goes to the EC for a final decision expected within two months. Approval will apply to all EU member states, as well as Iceland, Norway and Liechtenstein.

Currently, VYVGART is indicated for patients with generalised myasthenia gravis who are anti-acetylcholine receptor antibody positive.