Argenx Gears Up for US Launch of Vyvgart, Awaiting EU Decision
Argenx is working toward the commercial launch of Vyvgart (efgartigimod) — recently approved by the U.S. Food and Drug Administration (FDA) — to treat adults in the U.S. with generalized myasthenia gravis (gMG) who have the most common type of MG-driving antibody.
Vyvgart currently is up for possible approval in the European Union and Japan for treating gMG patients. Argenx is expecting regulatory decisions to be issued this year.
“We enter 2022 very excited about the year ahead, having achieved our first FDA approval and initiated our commercial launch of Vyvgart in the United States,” Tim Van Hauwermeiren, CEO of Argenx , said in a press release.
“With these accomplishments, we are well on our way to realizing our goal to become a leading, multi-product immunology company and believe we have the right team, a differentiated pipeline, and a sustainable innovation engine to support our vision,” Hauwermeiren said.
Argenx is planning to establish a Canada-based branch (Argenx Canada) early this year, in preparation for potential regulatory approval and commercial launch of Vyvgart in that country.
Additionally, one Argenx partner, Zai Lab, is planning to seek approval in China, and another, Medison, is gearing up to request Vyvgart’s approval in Israel. Both applications are expected to be submitted midway through this year.
Beyond these existing partnerships, Argenx is planning to forge new alliances in the new year, which “would expand global patient reach,” according to the company.
MG, a chronic autoimmune neuromuscular condition, is driven by antibodies that interfere with the communication between nerve and muscle cells. The most common type of these disease-causing antibodies targets a protein receptor, called an acetylcholine receptor, that plays a key role in this process.
Vyvgart, given by infusion into the bloodstream, is designed to increase the rate at which certain types of antibodies are recycled by blocking a protein that normally prevents their degradation. In doing so, it lowers the levels of disease-driving antibodies in the body.
An ongoing Phase 3 trial, called ADAPT-SC (NCT04735432), is comparing this approved formulation against another formulation given by under-the-skin (subcutaneous) injection. The main goal of that study, also sponsored by Argenx and involving 111 adults with gMG, is to determine the effect of treatment on antibody levels. Results from this trial are expected by the end of March.
Argenx also is running a Phase 2/3 trial (NCT04833894) testing the infused formulation of Vyvgart in children and adolescents with gMG, ages 2–17. This study is recruiting participants in Georgia, in the U.S., and in Spain.
Outside of continued research in gMG, Argenx also is running several trials testing Vyvgart in other conditions in which lowering antibody levels may be beneficial. The Netherlands-based immunology company is planning to launch more trials in the coming year.
“We expect to report data from five registrational trials by the end of the first quarter of 2023 and to initiate trials in four new indications this year,” Hauwermeiren said.
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