argenx SE, a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer, announced in December 2021 that the FDA approved VYVGART (efgartigimod alfa-fcab) for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.
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 will commercialize the first-and-only FDA approved neonatal Fc receptor blocker, VYVGART (efgartigimod alfa-fcab) for the treatment of adult gMG patients who are anti-acetylcholine receptor (AChR) antibody positive.
Soleo Health, an innovative leader and national provider of complex specialty pharmacy services, recently announced it was selected as a limited distribution partner for VYVGART.
Effective immediately, Soleo Health is able to manage and administer VYVGART intravenously in patients’ homes or its ambulatory infusion centers nationwide. Patients are supported through Soleo Health’s Myasthenia Gravis Therapeutic Care Management Center (TCMC).
The TCMC is staffed with specially trained interdisciplinary teams, comprising highly-experienced therapy care pharmacists, registered nurses, reimbursement specialists and patient care ambassadors dedicated to supporting patients living with myasthenia gravis.
Soleo Health has extensive experience administering specialty pharmaceuticals for rare and ultra-rare diseases and a strong commitment to enhancing patient experiences and outcomes. Additionally, Soleo Health offers differentiated capabilities through its ability to collect real-world data and generate intelligent outcomes from VYVGART patients with its exclusive and proprietary clinical outcomes program, SoleMetrics®.
According to the Myasthenia Gravis Foundation of America, gMG affects approximately 36,000 to 60,000 people in the U.S. However, gMG remains underdiagnosed in patients, and its prevalence is likely higher.
argenx is committed to supporting affordable access to VYVGART. As part of this commitment, argenx is launching My VYVGART Path, a program designed to connect patients and clinicians to personalized support throughout the treatment journey.
Program resources include disease and product education, access support and benefits verification, and financial assistance programs for eligible patients. Patients and healthcare providers can visit VYVGART.com for more information.
Specialty pharmacies also included in the limited distribution network for VYVGART are: Accredo Specialty Pharmacy, Option Care Health, CVS Specialty, AcariaHealth Pharmacy, and Optum.
Takeaway: Soleo Health’s growing limited drug distribution portfolio continues to expand, particularly within the autoimmune and neurology arenas