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Argenx Secures EC Approval for Subcutaneous VYVGART in CIDP Treatment

Maham Fatima

2 min read

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Argenx (NASDAQ:ARGX) is one of the best biotech stocks to invest in now. On June 20, Argenx announced that the European Commission/EC approved VYVGART (efgartigimod alfa) 1000mg for subcutaneous/SC injection. The approval is for its use as a monotherapy in adult patients with progressive or relapsing active chronic inflammatory demyelinating polyneuropathy/CIDP who have previously been treated with corticosteroids or immunoglobulins.

VYVGART SC is available as a vial or prefilled syringe and offers a flexible administration option, which allows it to be given by a patient, caregiver, or healthcare professional. Treatment begins with a weekly dose regimen, which can be adjusted to every other week based on clinical evaluation. This marks the first approval of an IgG Fc-antibody fragment specifically targeting the neonatal Fc receptor (FcRn) for CIDP in Europe, and it represents the first novel mechanism of action for CIDP treatment in 30+ years.

Argenx Secures EC Approval for Subcutaneous VYVGART in CIDP Treatment

Argenx Secures EC Approval for Subcutaneous VYVGART in CIDP Treatment

A lab setting filled with scientific equipment and researchers in lab coats working together to develop new therapies for autoimmune diseases.

The EC’s decision follows a positive recommendation from the Committee for Medicinal Products for Human Use/CHMP and is supported by the results of the ADHERE clinical trial, which is the largest study conducted to date on CIDP patients. CIDP is a rare, debilitating, and often progressive immune-mediated neuromuscular disorder affecting the peripheral nervous system. The EC approval covers all 27 European Union Member States, as well as Iceland, Liechtenstein, and Norway.

Argenx (NASDAQ:ARGX) is a commercial-stage biopharma company that develops various therapies for the treatment of autoimmune diseases in the US, Japan, China, the Netherlands, and internationally.

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Disclosure: None. This article is originally published at Insider Monkey.