11:41 AM EDT, 04/28/2025 (MT Newswires) -- Halozyme Therapeutics ( HALO ) said Monday its license partner, argenx, received a positive opinion for VYVGART from the European Medicines Agency's Committee for Medicinal Products for Human Use to treat adults with chronic inflammatory demyelinating polyneuropathy.

The subcutaneous injection of VYVGART is co-formulated with Halozyme's ENHANZE drug delivery technology. CIDP is a rare and serious autoimmune disease of the peripheral nervous system.

The CHMP recommendation for European Commission approval of the monotherapy across European Union member states is based on results from an earlier clinical trial, the company said.

The European Commission decision on marketing authorization application is expected within approximately two months, the company added.

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