Biotech company Argenx gets go-ahead in US for drug to treat autoimmune diseases

The US Food and Drug Administration (FDA) has given Belgian biotech company Argenx approval to market a key drug against autoimmune diseases.

The FDA has authorised Argenx to market Vyvgart Hytrulo for patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) a rare nervous disease. Treatment involves a weekly 30- to 90-second injection. Vyvgart Hytrulo is the first new treatment for CIDP in more than 30 years, Argenx says.

CIDP is a rare and debilitating disease that affects the peripheral nervous system. Patients may have difficulty getting up, experience pain and fatigue and often trip or fall. The drug, according to the results of the clinical trial on which the FDA relied to make a judgement, is said to improve 69 per cent of patients' mobility, function and strength. It is also said to reduce the risk of relapse by 61 per cent. 

Vyvgart Hytrulo is already being used against the muscle disease myasthenia gravis. Sales of Vyvgart accounted for 1.19 billion USD last year, including 374.35 million in the closing quarter.


Belgian prime minister Alexander De Croo and European Commissioner Margrethe Vestager visit Argenx in Zwijnaarde, East Flanders, February 2024 © BELGA PHOTO BENOIT DOPPAGNE

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