Vyvgart for efgartigimod infusion now approved in Israel for gMG
Under-the-skin treatment formulation now under review in US
Vyvgart (efgartigimod alfa-fcab) is now approved in Israel for the treatment of generalized myasthenia gravis (gMG), according to its developer, Argenx.
This is the second new approval for Vyvgart in gMG this year, following a similar positive decision in the U.K. in March. The therapy has been approved in the U.S. since late 2021, and last year it won approvals in Japan and the European Union. Argenx now is in the process of negotiating the therapy’s price and reimbursement in more than 10 countries in Europe.
“Throughout the first quarter, we made significant progress advancing our mission to redefine what well-controlled means in the treatment of autoimmune diseases,” Tim Van Hauwermeiren, CEO of Argenx, said in a press release, noting that the company is aiming to “grow Vyvgart as a new standard of care in gMG.”
Approvals in other countries have specifically covered Vyvgart’s use in adults with gMG who are positive for antibodies against acetylcholine receptor (AChR), the most common type of MG-driving antibody. Argenx did not provide details about the specific indications covered by the new Israeli approval.
Per a 2022 agreement, Argenx will be commercializing Vyvgart in Israel in partnership with Medison Pharma. The companies also have agreed to cooperate on commercializing the therapy in more than a dozen countries in Europe.
Argenx awaiting decisions on Vyvgart in China, Canada
MG is caused by self-reactive antibodies that interfere with the communication between nerve and muscle cells, resulting in muscle weakness and other disease symptoms. Vyvgart is designed to lower the levels of disease-driving antibodies by blocking the activity of the neonatal Fc receptor, a protein that normally helps prevent antibodies circulating in the bloodstream from being destroyed.
The therapy is administered intravenously, via infusion into the bloodstream. One cycle of treatment consists of four hour-long infusions given over the course of four weeks. Additional treatment cycles are given as needed based on patient response.
Findings from a Phase 3 clinical trial called ADAPT (NCT03669588) showed that Vyvgart, given on top of standard therapy, was more effective than a placebo at easing MG symptoms. More recent data from the extension study ADAPT+ (NCT03770403) showed that additional cycles of Vyvgart treatment had a consistent symptom-easing effect.
Vyvgart is up for potential approval in China and Canada.
Argenx also is developing a formulation of efgartigimod, Vyvgart’s active agent, that is administered by under-the-skin, or subcutaneous, injection. The new formulation is under review in the U.S., with a decision expected by June 20.
Subcutaneous efgartigimod also is up for approval in the EU — where a decision is expected by the end of the year — and in Japan, with a decision in that country expected in early 2024.
“Our team remains focused on continued expansion within gMG with our planned launch of [subcutaneous] efgartigimod and upcoming global regulatory approvals,” Van Hauwermeiren said.