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Launch of novel drug for rare neuromuscular disorder seeks to give voice to the patients.
Typically, advertising campaigns will make sure to include the product’s name, for obvious reasons. However, one biopharma company was confident enough in its new drug to take a different approach. Instead, it decided to focus its marketing on a message that would appeal to people suffering from a rare disease.
In December 2021, FDA approved Vyvgart (efgartigimod alfa-fcab), produced by Argenx, to treat patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive. While gMG is a rare autoimmune disease, the majority of patients who suffer from the condition are AChR positive.
gMG is a chronic neuromuscular disease that can cause severe, even life-threatening muscle weakness. It targets certain muscle receptors, blocking signals from the brain that cause the weakness. The chronic autoimmune disease prompts the patient’s immune system to start attacking its own body.
For patients with AChR antibodies, Vyvgart works by binding with neonatal Fc receptors (FcRn), causing a reduction in the IgGautoantibodies. Vyvgart is the first Fc receptor blocker approved by FDA.
Aside from muscle weakness, patients suffering from gMG may experience blurred vision, drooping eyelids, difficulty speaking, and shortness of breath. While patients often live a normal lifespan with the disease, their quality of life is significantly affected.
gMG effects between 14–40 out of 100,000 people in the US. Men with the disease will typically see their symptoms peak in their 50s and 60s, while women will often experience peak symptoms much earlier in life, during their 20s and 30s. It is possible for victims to suffer from symptoms at any age, however. In its global Phase III ADAPT trial (prior to FDA approval), about 68% of patients who received Vyvgart saw a reduction on the MG-ADL scale, while only 30% of patients who received the placebo saw similar results.
Kelsey Kirk, associate director, corporate communications, Argenx, tells Pharm Exec in a statement, “We are very pleased with the progress of our Vyvgart launch thus far. With carefully crafted strategies, our teams were well prepared going into approval, which set the stage for strong performance throughout the first two quarters delivering on two commercial launches: one in the United States and one in Japan. We also recently received approval from the European Commission, and the team in Europe is ready to hit the ground running. We have learned firsthand from listening to the community and through our research what a devastating and debilitating disease gMG can be. With its novel mechanism of action, Vyvgart has the potential to transform the treatment landscape and improve patients’ lives. Hearing stories from patients who are already experiencing benefits of this treatment has been the most rewarding aspect of the last six months. At the close of the second quarter, we reported approximately 1,400 patients on Vyvgart globally, which is a remarkable result from both our field teams’ engagement with physicians and from patients asking about Vyvgart by name. We’re proud of the strides we have made toward achieving our ultimate goal of empowering gMG patients to take more control of their treatment journey, and look forward to continuing this work for patient communities across the other disease targets we are evaluating in our pipeline.”
Shortly after FDA’s approval, Argenx CEO Tim Van Hauwermeiren announced that the company’s commercial team was ready to start delivering the product. A commercial advertising campaign launched, albeit with a twist.
The TV commercial focused on announcing the arrival of a new treatment for gMG, without actually naming the new drug. Instead, it directed viewers to NOW4gMG.com, a website that then directed visitors to the Vyvgart landing page.
The advertising focused on the difficulties that patients with gMG face every day. The commercial began by asking why people with gMG want a new treatment. It then featured several people explaining the limitations that the disease puts on them, such as making getting up and getting ready for work difficult, or how it prevents sufferers from going out to dinner with their friends. The TV spot also included a farmer who explained that the disease makes it hard for him to take care of his animals.
Vyvgart is Argenx’s first commercial launch. As part of the rollout, the company also launched a program called My Vyvgart Path with the goal of educating patients and clinicians while providing support. Patients can use the program to obtain benefits verification and financial support, if necessary.
In June, Spherix Global Insights announced the results of a survey that questioned neurologists about Vyvgart and its impact as a new treatment. The neurologists praised Vyvgart and explained that the drug’s action of blocking Fc receptors gave it an advantage of other forms of treatment for gMG. The company cited its targeted approach to blocking specific antibodies as an advantage, opposed to other medications that take a non-selective approach.
According to the data collected by Spherix, Vyvgart caught the attention of neurologists, who praised it for its high efficacy rates. The data also showed that Argenx’s sales team met with over half of the neurologists who participated in the survey as part of the company’s drive to raise awareness for the new treatment option.
At the end of July, the Galien Foundation announced its nominees for the best biotechnology products from the previous year, which included Vyvgart.
Read the profiles of all 2022 product launch selections here.
Mike Hollan is Pharm Exec’s Editor. He can be reached at firstname.lastname@example.org.