FDA Approves argenx's SC Vyvgart for Rare Neuromuscular Disorder

Argenx's Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase) has recently garnered FDA approval for treating adults with chronic inflammatory demyelinating polyneuropathy (CIDP). This approval is significant as it highlights Vyvgart Hytrulo as the first innovative precision medicine for this rare neuromuscular disorder in over thirty years.

The FDA's decision was supported by data from the Phase III ADHERE trial, which demonstrated that Vyvgart Hytrulo reduced the risk of relapse by 61% compared to a placebo, achieving the primary endpoint. Furthermore, 69% of the 322 trial participants who received the drug experienced various levels of clinical benefits, including enhanced mobility, function, and strength.

Jeffrey Allen, the principal investigator of the ADHERE trial, pointed out that conventional CIDP treatments, such as corticosteroids and plasma-derived therapies, can pose challenges for some patients. Vyvgart Hytrulo is anticipated to alleviate some of these treatment burdens, offering a more manageable option for those affected.

The approval of Vyvgart Hytrulo not only introduces a new treatment option for CIDP patients but also represents a significant market opportunity. Earlier this year, Takeda's immune globulin infusion also received approval for CIDP, indicating a growing interest and competition in this therapeutic space. Analysts and industry observers are keen to see how this competitive landscape evolves.

Beyond its application for CIDP, Vyvgart Hytrulo is also approved to treat generalized myasthenia gravis (MG). Last year, both the intravenous (IV) version of Vyvgart and the subcutaneous Hytrulo brand generated a combined revenue of $1.2 billion. UBS analysts have projected that Vyvgart could potentially yield up to $3 billion in revenue for MG treatments and more than $2 billion for CIDP.

The introduction of Vyvgart Hytrulo into the CIDP market not only provides a new therapeutic option for patients but also signifies a promising financial prospect for Argenx. As more treatments become available for CIDP, the competitive dynamics in this area are expected to intensify.