argenx’s Novel Treatment for Myasthenia Gravis gets FDA Nod

Around 65,000 people in the U.S. suffer from myasthenia gravis and approximately 85% have the generalized form of the disease which affects multiple organ groups throughout the body. Just like many autoimmune diseases, myasthenia gravis patients can either have their thymus removed or receive chemotherapy to turn off their immune systems. Myasthenia gravis is triggered by unknown reasons of attacks and interferences of an autoantibody of the immunoglobulin G (IgG) type on the signal transmission between the nerves and the muscle cells.

On December 17th, argenx announced the US FDA’s approval of Vyvgart (efgartigimod alfa-fcab) as the first-and-only treatment of generalized myasthenia gravis (gMG) in adults with anti-acetylcholine receptor (ACHR) antibody positive. Vyvgart is a neonatal Fc receptor blocker to reduce pathogenic IgGs, “an underlying driver of gMG,” according to Tim Van Hauvermeiren, CEO of argenx.

“The gMG community has long-awaited the FDA approval of Vyvgart, especially for those patients who struggle with basic personal tasks such as speaking, chewing and swallowing food, brushing teeth and hair, and in some severe cases, breathing,” commented Samantha Masterson, President and Chief Executive Officer of the Myasthenia Gravis Foundation of America. “We thank argenx for its continued commitment to the gMG patient community, which led them to deliver this much-needed new treatment option with the potential to change the lives of many gMG patients.”

Global Phase 3 ADAPT Study

The USFDA’s approval is based upon the results of the global Phase 3 ADAPT clinical study, published in the July 2021 issue of The Lancet Neurology. The study is a 26-week randomized, double-blind, placebo-controlled, multi-center trial with a total of 167 participants with gMG in North America, Europe and Japan. The enrollees were randomized in a 1:1 ratio to receive Vyvgart or placebo to evaluate the efficacy and safety of the therapeutics.

Different from the conventional clinical studies, the ADAPT study allows individualized treatment plans after an initial treatment cycle based on the individual patients’ circumstances. In doing so, the results provided a better understanding of individualized treatment and affordable access to Vyvgart as a reference for argenx’s launch of My Vyvgart Path, a program designed to personalize clinical support throughout the treatment journey. Argenx maintains its principles with several national and regional commercial payers of constructing a broader budget predictability and appropriate access for patients.

“Generalized myasthenia gravis imposes a significant lifestyle and treatment burden on patients, families, and the overall healthcare system. This autoimmune disease affects each patient differently which can create variability in dosing and the resulting cost per patient,” said Steve Miller, M.D., Executive Vice President and Chief Clinical Officer at Cigna Corp. “The approval of Vyvgart promises to address a treatment gap for patients suffering from this disease. argenx has put forth an innovative, value-based approach to contracting that will help payers with cost predictability as they face the challenge of ensuring real-world dosing remains affordable. This was a direct result of early engagement between argenx and Evernorth leading up to approval. Cigna looks forward to continued collaboration with argenx to enable appropriate access to the gMG patients who will benefit from Vyvgart.”

Expansion of Markets

argenx has an exclusive partnership agreement with Zai Lab for the development and commercialization of Vyvgart in Greater China, expecting approval by mid-2022 and a $25 million milestone payment. Argenx also has an exclusive partnership with Medison for commercialization of Vyvgart for the Israel market, expecting approval by the second quarter of 2022.

Author

Judy Ya-Hsuan Lin

Success is the ability to go from one failure to another with no loss of enthusiasm.