Soleo Health Selected as US Distributor for Vyvgart for gMG

Yedida Y Bogachkov PhD avatar

by Yedida Y Bogachkov PhD |

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Soleo Health, a pharmacy specializing in infusion therapies, will serve as the U.S. distributor that will administer Vyvgart (efgartigimod), the newly approved treatment for people with generalized myasthenia gravis (gMG).

Argenx, the therapy’s developer, selected Soleo Health as a limited distribution partner for Vyvgart, which was approved by the U.S. Food and Drug Administration (FDA) in December to treat adults with gMG who are positive for anti-acetylcholine receptor antibodies.

Soleo Health is at the forefront of bringing revolutionary specialty pharmaceuticals to patients nationwide with this new partnership with Argenx,” Drew Walk, Soleo’s CEO, said in a press release.

“Our ever-growing limited drug distribution portfolio continues to expand as we are increasingly recognized for our capabilities, particularly within the autoimmune and neurology arenas,” Walk said.

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Generalized MG is an autoimmune condition characterized by widespread muscle weakness. In most patients, it is caused by self-reactive antibodies that target and damage acetylcholine receptors, which play a key role in nerve-muscle communication and muscle contraction.

Vyvgart, given via intravenous (into-the-vein) infusion into the bloodstream, aims to ease MG symptoms by lowering the levels of these harmful serf-reactive antibodies. It does so by blocking a protein called neonatal Fc receptor (FcRn), which normally prevents certain antibodies circulating in the bloodstream from being broken down and recycled. Through this mechanism, Vyvgart increases the rate at which these antibodies, including those driving MG, are broken down.

With this new distribution agreement, Soleo Health can now manage and administer Vyvgart in patients’ homes or in its ambulatory infusion centers, allowing individuals with gMG to obtain treatment where it most suits them. The partnership is effective immediately, Soleo said.

Soleo’s Myasthenia Gravis Therapeutic Care Management Centers — each called a TCMC — are designed to help support patients on their MG journeys. The centers are staffed with specially trained nurses, pharmacists, reimbursement specialists, and patient care ambassadors, all dedicated to caring for MG patients. The TCMC network is further supported by specialty pharmacies with licenses in all 50 states.

Patients or providers who wish to learn more about Soleo Health’s administration of Vyvgart may contact the dedicated gMG Therapeutic Care Management Center via email at [email protected] or by calling toll-free 844-503-0912.

Additionally, Soleo is working to enhance patient experiences through its proprietary clinical outcomes program, SoleMetrics, which collects de-identified real-world data and generates intelligent outcomes from Vyvgart-treated patients. This program enables detailed reporting for physicians, health systems, and manufacturers, with a goal toward further improving patient care.

Vyvgart has now been approved in Japan to treat adults with gMG, regardless of antibody status, who failed to respond to steroids or nonsteroidal immunosuppressive therapies. The therapy is also currently under review in Europe, with a decision expected mid-year.