FDA Approves VYVGART Hytrulo Prefilled Syringe with ENHANZE for Self-Injection in gMG and CIDP
In a major development for patients suffering from chronic neuromuscular autoimmune disorders, Halozyme Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted approval to argenx for the self-injection version of VYVGART® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc). This prefilled syringe format enables adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive, as well as adults with chronic inflammatory demyelinating polyneuropathy (CIDP), to administer the therapy via a quick 20- to 30-second subcutaneous injection in a home or outpatient setting.
This latest regulatory milestone represents a significant leap forward in terms of treatment flexibility and autonomy, and it further deepens the value of Halozyme’s proprietary ENHANZE® drug delivery technology, which is at the core of this innovation. The approval allows for the therapy to be administered not only by healthcare professionals, but also by patients themselves or their caregivers, once they are adequately trained in the subcutaneous injection technique.
A More Patient-Centric Approach to Chronic Autoimmune Neurology
The prefilled syringe formulation of VYVGART Hytrulo offers a streamlined, simplified alternative to intravenous infusions or vial-based subcutaneous administration. According to Dr. Helen Torley, President and Chief Executive Officer of Halozyme, the FDA approval underscores the company’s commitment to making life-changing therapies more accessible and less burdensome for patients.
“The FDA approval of VYVGART Hytrulo prefilled syringe represents a significant advancement in treatment options for gMG and CIDP patients, enabling self-administration by patients and potentially further reducing the burden of treatment,” Dr. Torley said. “We are delighted that argenx continues to expand the use of Halozyme’s proven ENHANZE technology to support patient independence and convenience.”
Patients who live with gMG and CIDP typically require long-term immunomodulatory treatments to control their symptoms. These treatments have traditionally necessitated regular visits to healthcare facilities for administration—posing logistical, financial, and emotional challenges for patients and their families. The prefilled syringe introduces a greater degree of freedom and mobility into the care paradigm, aligning with ongoing industry trends toward decentralized care and at-home therapeutic management.
ENHANZE® Technology: Revolutionizing the Delivery of Biologics
The newly approved prefilled syringe formulation builds on the foundation of the previously approved VYVGART Hytrulo vial format. It leverages ENHANZE, Halozyme’s proprietary platform that utilizes recombinant human hyaluronidase PH20 (rHuPH20) to facilitate the subcutaneous delivery of large biologic molecules. By temporarily degrading hyaluronan in the extracellular matrix, ENHANZE enables the rapid dispersion and absorption of biologic drugs administered subcutaneously—transforming the delivery profile of these therapies from hours to mere seconds or minutes.
This enables higher drug volumes to be delivered in a single subcutaneous injection, allowing for more patient-friendly formulations that maintain efficacy and bioavailability.
The newly approved prefilled syringe version of VYVGART Hytrulo was developed through argenx’s exclusive partnership with Halozyme. The collaboration focuses on incorporating ENHANZE into argenx’s suite of immunology-focused monoclonal antibody therapies.
The approved formulation allows for a single-dose administration via prefilled syringe, requiring only 20 to 30 seconds for delivery. The simplicity and speed of this administration method hold particular promise for improving adherence to therapy in real-world settings, where complex infusion regimens can be a deterrent to sustained treatment.
Clinical and Regulatory Pathway: From Bioequivalence to Real-World Usability
The FDA’s approval of the prefilled syringe formulation of VYVGART Hytrulo was underpinned by a robust body of evidence, including bioequivalence studies comparing the prefilled syringe format to the previously approved subcutaneous vial version. The data demonstrated that the prefilled syringe delivers an equivalent therapeutic dose of efgartigimod alfa and hyaluronidase-qvfc, maintaining the same safety and efficacy profiles.
Furthermore, human factors validation studies were conducted to assess the ability of patients with gMG or CIDP—or their caregivers—to accurately and safely administer the injection using the prefilled syringe format. These studies confirmed that participants could successfully follow instructions, prepare the injection, and deliver the therapy without major errors or adverse outcomes.
This approval follows the FDA’s prior authorizations of VYVGART Hytrulo in a vial format for both gMG and CIDP. Those approvals were based on compelling evidence generated from several pivotal clinical trials:
- ADAPT (gMG): A Phase 3 global clinical trial that demonstrated the clinical efficacy and safety of efgartigimod in improving muscle strength and daily functioning in AChR antibody-positive gMG patients.
- ADAPT-SC (gMG): This trial further validated the subcutaneous formulation of efgartigimod co-formulated with Halozyme’s ENHANZE, demonstrating non-inferiority to the intravenous version.
- ADHERE (CIDP): A Phase 3 clinical trial evaluating the efficacy of VYVGART Hytrulo in CIDP, a rare autoimmune disorder where the body’s immune system attacks peripheral nerves. The study confirmed significant improvements in neurological function and reduced relapse rates.
The Expanding Landscape of Immunomodulatory Therapies
The approval of VYVGART Hytrulo prefilled syringe comes at a time when the autoimmune neurology field is experiencing rapid innovation. gMG and CIDP are both conditions that arise from immune system dysregulation, leading to chronic, progressive neuromuscular symptoms. These diseases are often debilitating, with fluctuating or worsening weakness, fatigue, and loss of motor function.
Traditional treatment regimens include corticosteroids, immunosuppressants, plasmapheresis, and intravenous immunoglobulin (IVIg). However, these approaches are often associated with significant side effects and long-term complications. The emergence of targeted biologics like efgartigimod offers new therapeutic avenues with improved efficacy and tolerability.
VYVGART (efgartigimod alfa) is a fragment of a human IgG1 antibody that binds to the neonatal Fc receptor (FcRn), reducing the recycling of pathogenic IgG antibodies that drive autoimmune responses. Its novel mechanism of action has positioned it as a first-in-class therapy in gMG, and its application in CIDP has expanded its therapeutic reach.
The combination with Halozyme’s ENHANZE has not only enhanced the administration profile of efgartigimod but also reinforced the strategic value of platform-based drug delivery innovation in biologics.
A Strategic Collaboration Driving Next-Generation Therapies
The successful approval of the VYVGART Hytrulo prefilled syringe reinforces the strength of the argenx-Halozyme partnership, which continues to yield transformative delivery solutions for complex biologic therapies. This collaboration exemplifies how biotech innovation, when integrated thoughtfully into drug development pipelines, can yield products that address patient-centric needs without compromising therapeutic impact.
For Halozyme, it’s a continuation of a broader corporate strategy to license ENHANZE to biopharmaceutical developers looking to optimize the delivery of monoclonal antibodies, fusion proteins, and other biologics. ENHANZE is currently used in multiple approved products across oncology, immunology, and other indications—further affirming its versatility and value.
