argenx Announces Approval of VYVDURA® (efgartigimod alfa and hyaluronidase-qvfc) Injection for Subcutaneous Use in Japan for Generalized Myasthenia Gravis
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The approval of VYVDURA by Japan's Ministry of Health, Labour and Welfare represents a significant advancement for the treatment landscape of generalized myasthenia gravis (gMG) in Japan. This is particularly important considering the chronic nature of gMG and the limited treatment options previously available. The introduction of a subcutaneous (SC) formulation offers a new administration route that could improve patient compliance and quality of life by allowing self-administration at home.
From a medical research perspective, the positive results from the Phase 3 ADAPT-SC study are crucial as they provide the evidence needed for regulatory approval. The study's ability to demonstrate comparable efficacy in reducing total immunoglobulin G (IgG) levels between the SC and intravenous (IV) formulations is a key factor in offering patients flexibility in their treatment regimen. It is important to note that IgG reduction is a therapeutic target in gMG management, as it is associated with symptom amelioration.
The long-term implications for stakeholders include potential market expansion and increased treatment adherence, which can lead to better patient outcomes. However, the introduction of a new treatment option also requires careful post-marketing surveillance to monitor real-world effectiveness and safety.
The approval of VYVDURA could potentially disrupt the current gMG treatment market in Japan by providing a differentiated product that addresses patient convenience and treatment adherence. The ability for patients to self-administer the medication at home is a significant competitive advantage that could influence prescribing patterns and patient preference.
From a market perspective, the dual availability of both IV and SC formulations of VYVGART could lead to an increase in the overall market share for argenx SE within the immunology and autoimmune space. This strategy might also serve as a defense against competitive pressures, including upcoming biosimilars or novel therapies. The company's commitment to the Japanese market is evident and could result in strengthened relationships with local healthcare providers and patient advocacy groups.
It is essential to monitor the adoption rate of VYVDURA in the coming quarters, as it will provide insights into its market impact and potential to generate revenue for argenx SE. Additionally, the pricing strategy and reimbursement policies will play a significant role in determining its commercial success.
The economic implications of introducing VYVDURA in Japan's healthcare system are multifaceted. For the healthcare economy, the availability of an SC formulation could lead to a reduction in healthcare resource utilization, as patients may require fewer visits to healthcare facilities for IV administration. This can translate into cost savings for both healthcare providers and patients, especially when considering the chronic management required for gMG.
However, it is also important to consider the cost-effectiveness of the new treatment option. The initial drug cost, long-term economic benefits of improved disease management and potential reduction in gMG-related complications must be evaluated. Japan's national healthcare system, which emphasizes cost containment, will likely scrutinize the pricing of VYVDURA to ensure that it aligns with the value it provides to patients and the system as a whole.
Furthermore, the broader impact on the healthcare economy includes potential shifts in labor dynamics within healthcare settings, as the need for specialized staff to administer IV treatments may decrease. This could allow for a reallocation of resources to other areas of patient care, optimizing the overall efficiency of healthcare delivery for autoimmune diseases.
- Availability of VYVGART® and self-administered VYVDURA demonstrates continued commitment to providing more choice and flexibility for gMG patients in Japan
Jan. 18, 2024, 7:00 AM CET
Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) approved VYVDURA® (efgartigimod alfa and hyaluronidase-qvfc) injection for subcutaneous (SC) use for the treatment of adult patients with generalized myasthenia gravis (gMG), who do not have sufficient response to steroids or non-steroidal immunosuppressive therapies (ISTs). Following this decision, VYVGART is now approved in Japan for both intravenous (IV) and self-administered SC use.
“Today’s approval of VYVDURA marks a significant milestone for the gMG community in Japan and furthers our commitment to deliver innovative treatments to autoimmune patients globally,” said Hermann Strenger, General Manager, argenx Japan. “Bringing VYVDURA to Japan means there are now two formulations available for gMG patients, including the possibility to self-inject at home, allowing patients and their healthcare providers to choose the best option to meet their treatment needs.”
The approval of VYVDURA is based on positive results from the Phase 3 ADAPT-SC study. ADAPT-SC established the efficacy of VYVDURA by demonstrating a reduction in percent change from baseline in total immunoglobulin G (IgG) levels comparable to VYVGART IV in adult gMG patients. ADAPT-SC was a bridging study to the Phase 3 ADAPT study, which formed the basis for approval of VYVGART in Japan in January 2022.
About the ADAPT-SC Trial
The Phase 3 ADAPT-SC trial was a multicenter, randomized, open-label, parallel-group study evaluating the noninferiority of the pharmacodynamic (PD) effect of VYVDURA compared with VYVGART in adult patients with gMG. The pharmacodynamic effect was measured by percent change from baseline for both total IgG and AChR autoantibody levels at day 29. Safety, clinical efficacy, immunogenicity and pharmacokinetics (PK) were also assessed. A total of 110 adult patients with gMG in North America, Europe and Japan enrolled in the ADAPT-SC trial. Patients were randomized in a 1:1 ratio to receive VYVDURA or VYVGART for one treatment cycle consisting of four doses at once-weekly intervals. The total study duration was approximately 12 weeks, including seven weeks of follow-up after the treatment cycle. At the completion of ADAPT-SC, patients had the opportunity to roll-over to ADAPT-SC+, an open-label extension study.
About VYVDURA®
VYVDURA is a subcutaneous combination of efgartigimod alfa, a human IgG1 antibody fragment marketed for intravenous use as VYVGART®, and recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE® drug delivery technology to facilitate subcutaneous injection delivery of biologics. In binding to the neonatal Fc receptor (FcRn), VYVDURA results in the reduction of circulating IgG. VYVGART SC was approved in the United States in June 2023 and is marketed as VYVGART® Hytrulo.
About Generalized Myasthenia Gravis
Generalized myasthenia gravis (gMG) is a rare and chronic autoimmune disease where IgG autoantibodies disrupt communication between nerves and muscles, causing debilitating and potentially life-threatening muscle weakness. Approximately
About argenx
argenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx developed and is commercializing the first approved neonatal Fc receptor (FcRn) blocker in the U.S., Japan, Israel, the EU, the UK, Canada and China. The Company is evaluating efgartigimod in multiple serious autoimmune diseases and advancing several earlier stage experimental medicines within its therapeutic franchises. For more information, visit www.argenx.com and follow us on LinkedIn, Twitter, and Instagram.
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FAQ
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