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Argenx (NASDAQ:ARGX) has received FDA approval for Vyvgart Hytrulo for the treatment of adults with chronic inflammatory demyelinating polyneuropathy, or CIDP.
The Dutch biotech company said the product was the first and only neonatal Fc receptor blocker approved to treat the condition.
The product is co-formulated with Halozyme Therapeutics’ (HALO) proprietary recombinant human hyaluronidase enzyme, Enhanze, according to Halozyme.
Vyvgart Hytrulo is also approved by the FDA for the treatment of generalized myasthenia gravis in patients who are anti-acetylcholine receptor antibody positive.
(Adds that the product is co-formulated with Halozyme’s Enhanze.)
