, 2025-04-14 14:35:00
The US Food and Drug Administration (FDA) has approved a prefilled syringe for self-injection of efgartigimod alfa and hyaluronidase-qvfc (Vyvgart Hytrulo, argenx) in the treatment of adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor antibody positive and adults with chronic inflammatory demyelinating polyneuropathy (CIDP).
The prefilled syringe will be available as a 20-to-30-second subcutaneous injection by a patient or caregiver after appropriate training or by a healthcare professional.
The approval is supported by data from studies evaluating its bioequivalence to Vyvgart Hytrulo in a vial, the company said in a news release. Human factors validation studies also demonstrated that participants with gMG or CIDP, or their caregivers, safely and successfully prepared and administered the drug.
Efgartigimod alfa-hyaluronidase was approved by the FDA in June 2023 for gMG based on the phase 3 ADAPT and ADAPT-SC trials and in June 2024 for CIDP based on the ADHERE trial.
“This new self-injection option will lead to more convenient and flexile administration for patients, empowering them to decide when and where they receive treatment. A ready-to-use option enhances patient independence and reduces the time required for treatment, making disease management and control more seamless,” Beth Stein, MD, director of neuromuscular diseases, St Joseph’s Health, Clifton, NJ, said in the company news release.
“The daily burden of CIDP from both the symptoms of the disease and interruption to daily life creates profound unseen challenges for patients,” Lisa Butler, executive director, GBS-CIDP Foundation, added in the statement. “Effective new treatments that reduce the need for frequent clinic visits are a welcome option for active patients seeking to regain time and a sense of normalcy in their daily routine.”
The most common side effects of Vyvgart Hytrulo include respiratory tract infection, headache, urinary tract infection, and injection site reactions, according to the company.
The drug can also cause allergic reactions that can be severe and can happen during, shortly after, or weeks after injection, the company warns. Patients are advised to “tell your health provider or get emergency help right away if you have any of the follow symptoms of an allergic reaction: rash, swelling of the face, lips, throat or tongue, shortness of breath, hives, trouble breathing, low blood pressure, or fainting.”
Patients should monitor for clinical signs and symptoms of hypersensitivity for at least 30 minutes after administration, and seek medical attention if a hypersensitivity reaction occurs, according to prescribing information for the drug.