Agreement Reached to Market Efgartigimod in Israel, Europe

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by Mary Chapman |

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Medison Pharma has entered into a pact with the global immunology company Argenx to bring efgartigimod to market in Israel and across several European countries for treating adult patients with generalized myasthenia gravis (gMG).

The agreement sets the stage for commercialization of efgartigimod in 14 countries: Hungary, Poland, Czech Republic, Slovenia, Romania, Bulgaria, Lithuania, Croatia, Slovakia, Estonia, Latvia, Greece, Cyprus, and Israel.

The therapy, developed by Argenx, is approved in the U.S. as Vyvgart for adults with anti-acetylcholine receptor (AChR) antibodies — the most common type of MG-causing antibodies — and in Japan for all patients with refractory disease, antibody status notwithstanding.

The treatment is also being made available to qualified adults in the U.K. with gMG under an early access to medicines scheme, established to provide access to prospectively lifesaving medicines to those with unmet medical needs prior to the therapy’s regulatory approval. The therapy is under regulatory review in the European Union, with a decision expected later this year.

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“We are on a mission to help patients with severe rare diseases get faster access to highly innovative therapies, regardless of where they live in the world,” Meir Jakobsohn, Medison founder and CEO, said in a press release. “By partnering with argenx, we provide a force multiplier for this breakthrough therapy, helping to save and improve the lives of patients living with generalized myasthenia.”

Generalized myasthenia occurs when the immune system inadvertently creates antibodies that attack proteins such as AChRs that are required for nerve-muscle interaction.

The medication is delivered directly into the bloodstream and is crafted to inhibit the neonatal Fc receptor, which ordinarily prevents blood-borne antibodies from circulating. Blocking receptors means more disease-causing antibodies are eroded, reducing their levels and ultimately mitigating symptoms.

Top-line data from the Phase 3 ADAPT trial (NCT03669588) indicates that Vyvgart was generally well tolerated and resulted in sustained declines in symptom severity among patients with AChR antibodies. It also performed better than a placebo in patients who don’t have such antibodies.

After completing the trial, most participants entered an open-label extension study called ADAPT-Plus (NCT03770403), wherein they received the treatment for up to three years. Its main goals are to assess the treatment’s safety and tolerability for long-term use.  Researchers expect to complete the trial in mid-2023.

“We are proud to partner with argenx and help extend their reach to treat patients with severe autoimmune diseases in 14 countries,” Victor Papamoniodis, vice president of international markets with Medison, said. “We look forward to utilizing our unique commercial platform and applying our expertise to facilitate faster access to this novel therapy for patients across all our markets.

2021 Myasthenia Gravis Survey Results

BioNews Survey Infographic

Myasthenia Gravis News conducted a survey from Feb. 11-March 28 to gain greater insight into the characteristics of the MG community and disease management. Results of the survey have now been published. Click on the image to view the infographic, and click here to read the story.