After several CGRP inhibitor approvals in 2018, drugmakers are competing in—and looking to grow—the migraine prevention field. Lundbeck is set to be the latest to enter the fray following a nod for Vyepti last month, but can it succeed despite its late start and less convenient IV administration?
Lundbeck’s executive vice president of North America, Peter Anastasiou, thinks so. Even as several new migraine prevention drugs vie for market share, Anastasiou says the market is “underserved” as many patients are still on old drugs that “just aren’t very effective.”
“All of the new migraine prevention treatments can be successful,” Anastasiou said. “I firmly believe that.”
There are about 14 million U.S. patients who are eligible for preventive treatment, Anastasiou said, and most aren’t yet on a new preventive drug. But Vyepti is entering a field already occupied by Amgen's Aimovig, Eli Lilly's Emgality and Teva's Ajovy. Lundbeck’s new option is administered in 30-minute infusions every three months, compared with monthly subcutaneous injections for Aimovig and Emgality. Ajovy also offers quarterly dosing. Lundbeck plans to launch April 6.
The IV administration for Vyepti has raised concern from analysts, who believe the drug will be relegated to second-line use for patients who don’t succeed on other options.
The drug will likely "end up with a niche share in the market," Jefferies analysts wrote last year after speaking with two physician opinion leaders. RBC Capital Markets analyst Randall Stanicky, meanwhile, wrote last month after surveying 55 neurologists that Vyepti could capture about a 9% piece of the market.
For their part, analysts with GlobalData believe the drug will generate $566 million in 2025, compared with blockbuster sales projections for some of Vyepti’s rivals. Vyepti's IV infusion is a “much more time consuming and inconvenient route of administration compared with the subcutaneous injection of Vyepti’s competitors,” GlobalData analyst Philippa Salter said in a statement last month.
Anastasiou sees things differently. It’s “not overly burdensome” to have a 30-minute infusion every three months, he said. Plus, many doctors see migraine prevention patients typically once per quarter, so the dosing schedule “fits nicely” with current practices, he argued.
“At the end of the day, patients just want to get better,” he added.
For its launch, Lundbeck is first focusing on patients who are getting older preventive therapies such as antidepressants or antiepileptics, Anastasiou said. Some of those meds haven't shown strong efficacy or are associated with burdensome side effects.
Second, the company is aiming to reach patients who discontinued treatment on older therapies because they “lost hope,” he said.
But with the global COVID-19 pandemic ongoing, Lundbeck will have to navigate another challenge. Given that rivals can be administered in a patient’s home, those competitors likely hold an advantage during the crisis.
It "remains our mission to bring medications to these patients, especially during this unprecedented and challenging time," Anastasiou said.
The company has refocused its launch on providing information digitally, "so it is accessible to patients and healthcare providers on their own time and when they want it." Sales reps are also conducting appointments virtually, he added, and speaker programs will move online.
While the "possible impact of these circumstances is hard to predict," the company will do its best to support doctors and patients, Anastasiou said.
Meanwhile, even as drugs in the new CGRP class compete for share, Allergan’s Botox is still holding strong, RBC's Stanicky wrote last month. In the same survey of 55 neurologists, most responders said they would increase their Botox prescriptions in the coming year. And a new entrant from Biohaven could be nearing as the company this week said Nurtec hit its endpoint in a pivotal prevention trial.