FDA Approves Prefilled Syringe Version of Vyvgart for Easier At-Home Treatment

The U.S. Food and Drug Administration (FDA) has approved a new prefilled syringe version of Vyvgart, a widely-used treatment developed by Netherlands-based Argenx SE for rare autoimmune disorders. This new format offers patients a more convenient option for self-administration at home.

Vyvgart, which treats generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP), can now be delivered using a subcutaneous injection that takes just 20 to 30 seconds. The syringe version—called Vyvgart Hytrulo—includes Halozyme Therapeutics’ ENHANZE® drug delivery technology, making it suitable for use by patients, caregivers, or healthcare professionals after proper instruction.

Argenx says the new prefilled syringe will be available within two weeks and will be priced similarly to the existing subcutaneous vial version. The company believes this added convenience will improve access to the drug, empower patients with more independence, and potentially broaden Vyvgart’s use earlier in treatment plans.

CEO Tim Van Hauwermeiren noted that this development makes Vyvgart more competitive with oral medications and enhances the overall treatment experience for patients living with these chronic conditions.

Following the FDA’s announcement, Argenx shares jumped nearly 9%, reflecting growing investor confidence in the expanded product line.