#United States #San Diego #Halozyme #CIDP #VYVGART®

Halozyme's Milestone for CIDP Treatment

Halozyme Therapeutics, a notable name in the biopharmaceutical industry, has recently made headlines with its announcement concerning a significant step in the treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). The company revealed on April 28, 2025, that argenx has received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) regarding its application for VYVGART® (efgartigimod alfa), which is specially formulated for subcutaneous injection using Halozyme's proprietary ENHANZE® technology. This move is likely to pave the way for VYVGART® to become a key therapeutic option for patients suffering from CIDP.

CIDP is a serious condition that affects the peripheral nervous system, leading to progressive weakness and sensory loss. Traditionally, treatments have included corticosteroids and immunoglobulins, but for many patients, these options can be insufficient or lead to adverse effects. The introduction of VYVGART® marks a pivotal moment, as it will be the first targeted IgG Fc-antibody fragment specifically for CIDP and the first novel mechanism of treatment in over three decades.

Importance of the CHMP Recommendation

Dr. Helen Torley, President and CEO of Halozyme, expressed her enthusiasm regarding the CHMP's positive opinion, highlighting its potential impact on European patients. She noted, "The positive CHMP opinion moves argenx closer to offering patients throughout Europe a groundbreaking new treatment option." The recommendation follows encouraging results from the ADHERE clinical trial, which stands as the largest study of CIDP patients to date. This trial’s promising findings have set the stage for potential EC approval within the next couple of months, impacting not only the 27 EU member states but also Iceland, Norway, and Liechtenstein.

The recommended VYVGART® is available both as a vial and a prefilled syringe, providing flexibility in administration—allowing patients, caregivers, or healthcare professionals to deliver the treatment. This ease of use is anticipated to significantly improve the overall patient experience by making treatment more accessible.

Halozyme's Role and Future Prospects

Halozyme is known for its innovative contributions to drug delivery technologies, encapsulated in its ENHANZE® system. This proprietary technology aims to enhance the efficacy of subcutaneous therapies, allowing for quick administration and a reduced burden on patients. The success of ENHANZE® can be seen in its collaborations across the pharmaceutical industry, including partnerships with giant firms like Roche and Pfizer. With over a million patients having benefitted from products utilizing ENHANZE® in various therapeutic areas, the technology is seen as a game-changer in biopharmaceuticals.

Moreover, Halozyme's strategic direction includes developing drug-device combination products that offer enhanced convenience and better patient adherence.

As the healthcare landscape continues to evolve, innovations like VYVGART® could radically reshape approaches to complex conditions like CIDP, offering new hope to those impacted by these challenging disorders. As the European Commission deliberates on the CHMP's recommendation, all eyes will be on argenx and Halozyme, eagerly awaiting the announcement of possible approval and the beginning of a new chapter in CIDP treatment.

For further updates, stakeholders are encouraged to track the progress of VYVGART® through ongoing communications from Halozyme and argenx, as the world watches this promising therapy inch closer to market availability.