FDA OKs self-injectable Vyvgart Hytrulo for neuromuscular conditions

Key takeaways:

• The approval applies to certain patients with myasthenia gravis or chronic inflammatory demyelinating polyneuropathy.
• An expert said the new option allows patients “to manage their condition more independently.”

The FDA has approved a subcutaneous self-injectable for adults with generalized myasthenia gravis who are anti-acetylcholine receptor antibody positive and adults with chronic inflammatory demyelinating polyneuropathy.

In a press release, manufacturer argenx stated that its prefilled syringe for self-injection of Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) can be administered by caregivers, health care professionals or patients in 20 to 30 seconds.

“As a neuromuscular specialist, a self-injectable treatment option has the potential to meaningfully improve the treatment experience for patients living with generalized myasthenia gravis (gMG) and [chronic inflammatory demyelinating polyneuropathy (CIDP)],” Beth Stein, MD, director of neuromuscular diseases at St. Joseph’s Health in Clifton, New Jersey, who is not affiliated with the drug’s development, told Healio. “It enables patients to manage their condition more independently, reducing the need for frequent visits and allowing greater control over their daily lives.”

The approval of the prefilled syringe formulation was supported by data from bioequivalence studies. In addition, human-factor validation studies showed that individuals with gMG or CIDP or their caregivers were able to safely and successfully prepare Vyvgart Hytrulo with the prefilled syringe.

In June 2023, the FDA approved subcutaneously administered Vyvgart Hytrulo with Enhanze in adults with gMG who are also anti-acetylcholine receptor antibody positive. In June 2024, Vyvgart Hytrulo was approved in a once-weekly, 30- to 90-second subcutaneous injection for adults with CIDP.

“Today’s FDA approval provides a new self-injection option across both approved indications in the U.S. that is designed for patients who seek more independence with their treatment,” Luc Truyen, MD, PhD, argenx chief medical officer, said in the release. “Whether patients prefer to receive their treatment in a physician’s office, at home or while traveling, they can experience treatment on their own terms.”