Under-the-skin Vyvgart approved in Europe for AChR-positive gMG

Argenx to work with health authorities for access in all EU member states

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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A new under-the-skin injectable formulation of Vyvgart (efgartigimod alfa) has been approved by the European Commission for adults with generalized myasthenia gravis (gMG) who are positive for antibodies targeting the acetylcholine receptor (AChR) — the most common type of MG-causing antibody.

This subcutaneous (under-the-skin) formulation now can be used as an add-on to standard treatment for those with gMG in the European Union.

The approval covers all EU member states, plus Iceland, Norway, and Liechtenstein. It comes just a few months after a positive recommendation from a committee of the European Medicines Agency (EMA), and scarcely more than a year after the EU approval of the original formulation of Vyvgart. That formulation is administered by an intravenous — IV or into-the-vein — infusion into the bloodstream.

Argenx, the company that markets Vyvgart, said it will be working with health authorities in these European countries to secure patient access to the new subcutaneous formulation.

“[This] approval reflects our commitment to providing a choice of effective, innovative therapies to people with autoimmune disease. We are proud to deliver this second formulation to the European gMG community, just 15 months after the initial approval of Vyvgart IV,” Anant Murthy, general manager of Argenx in Europe, the Middle East, and Africa, said in a company press release.

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The subcutaneous formulation of Vyvgart also was approved a few months ago in the U.S., where it’s sold under the name Vyvgart Hytrulo.

Vyvgart is designed to reduce the levels of the self-reactive antibodies that cause MG. The therapy specifically works by blocking the activity of neonatal Fc receptor (FcRn), a protein that normally helps to stabilize antibodies circulating in the bloodstream and prevent their destruction. That, in turn, can increase the rate at which self-reactive antibodies are broken down.

Clinical trials of the IV formulation of Vyvgart have shown that the therapy can reduce MG symptom severity compared with a placebo.

Both the new subcutaneous version of Vyvgart and the older intravenous formulation are administered in an initial cycle of four injections or infusions over the course of four weeks, with additional four-week rounds of treatment given as needed. Argenx developed the subcutaneous formulation using drug delivery technology from Halozyme with the aim of making treatment more convenient for patients.

“The availability of two formulations, including the possibility for patients to self-administer at home, allows people living with gMG to choose the treatment that best works for their lifestyle, further reinforcing the individualized treatment approach offered by Vyvgart,” Murthy said.

Approval of the new subcutaneous formulation was based on data from the Phase 3 ADAPT-SC trial (NCT04735432), which compared the subcutaneous and intravenous formulations in 110 people with gMG. The results showed that both formulations were similarly effective at lowering antibody levels and easing symptom severity.