FDA approves under-the-skin injection Vyvgart for the treatment of a muscle-weakening genetic disease called generalized myasthenia gravis. - argenx
The FDA has approved Argenx SE's under-the-skin injection for the treatment of a muscle-weakening genetic disease called generalized myasthenia gravis.
The drug, branded as Vyvgart Hytrulo, is expected to be available in the U.S. next month and will come at a list price of $15,773. The FDA had approved an intravenous version of the drug in 2021 under the brand name Vyvgart, but the company expects an under-the-skin version to offer more convenient dosing than infusion into the veins. Vyvgart generated more than $400 million in global sales last year.
The safety and efficacy of Vyvgart were evaluated in a 26-week clinical study of 167 patients with myasthenia gravis who were randomized to receive either Vyvgart or placebo. The study showed that more patients with myasthenia gravis with antibodies responded to treatment during the first cycle of Vyvgart (68%) compared to those who received placebo (30%) on a measure that assesses the impact of myasthenia gravis on daily function. More patients receiving Vyvgart also demonstrated response on a measure of muscle weakness compared to placebo. .
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