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Friday, the FDA approved Argenx SE’s (NASDAQ:ARGX) Vyvgart Hytrulo for use in patients with chronic inflammatory demyelinating polyneuropathy (CIDP).
Vyvgart Hytrulo is approved for CIDP as a once-weekly 30-to-90-second subcutaneous injection. It is the first and only neonatal Fc receptor (FcRn) blocker approved for CIDP.
CIDP is an autoimmune disorder in which the body’s immune system attacks the myelin that insulates and protects the body’s nerves. It causes muscle weakness, numbness, and other symptoms.
The FDA approval is based on the ADHERE Study that showed that 69% (221/322) of patients treated with Vyvgart Hytrulo, regardless of prior treatment, demonstrated evidence of clinical improvement, including improvements in mobility, function, and strength.
ADHERE met its primary endpoint demonstrating a 61% reduction in the risk of relapse versus placebo.
Vyvgart Hytrulo is also approved in the U.S. for generalized myasthenia gravis in adult patients who are anti-acetylcholine receptor antibody positive.
William Blair writes the approval comes with a best-case scenario broad label.
Management mentioned during the call that the estimated annual net price per patient is about $450,000. They believe there are around 12,000 patients in the U.S. who are not effectively treated with current therapies, and these patients will be the focus of the initial launch.
William Blair writes the company has observed that due to the chronic nature of CIDP, many patients are cautious about switching treatments when they respond well to current options like IVIg. Consequently, the initial focus has been on patients who are refractory to treatments rather than those switching early.
Based on this approach, CIDP revenues are projected to be $28.7 million in 2024, rising to $1.2 billion in the U.S. by 2030 for this indication alone.
The analyst reiterates Argenx with a Market Perform rating.
Read Next: Argenx’s Autoimmune Trial Stumble: Analysts Cut Price Targets, Warn of Risky Outcomes.
Price Action: ARGX shares are up 12% at $441.70 at last check Monday.
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Posted In: ARGX
