After a 54% year-over-year sales increase for CGRP migraine drug Vyepti in the U.S., Lundbeck has raised its peak sales projection for the therapy in the key market.
The Danish company now expects the CGRP blocker to reach more than $1.1 billion in sales at peak in the U.S., a $100 million increase from its previous guidance. In the second quarter, Vyepti’s sales were 1.83 billion Danish kroner ($287 million) in the States, representing 87% of the drug's global total.
Vyepti is the only infused CGRP med in a drug class filled with oral pills and under-the-skin injectables. Approved by the FDA in 2020 to prevent migraine episodes, Vyepti was the fastest-growing anti-CGRP agent in the U.S. as of June, with its demand growth of 50% year over year versus 20% for the overall market, according to Lundbeck.
To fuel Vyepti’s growth, Lundbeck has invested in healthcare provider engagement, patient activation and patient support services, Tom Gibbs, head of Lundbeck’s U.S. operations, said in an investor call Thursday.
“We continue to see accelerating demand by driving depth and breadth of prescribing of Vyepti and continued positive momentum in new patient starts supported by a high written-to-infusion conversion ratio and best-in-class patient persistency,” Gibbs said.
Vyepti’s rollout has benefited from a sweeping capital reallocation initiative launched after Lundbeck’s current CEO Charl van Zyl joined in 2023. The goal is to channel resources to strategic brands such as Vyepti and the antipsychotic Rexulti, plus key R&D projects. Toward that end, Lundbeck last year transferred U.S. rights and promotion responsibility around the depression drug Trintellix to its partner Takeda.
The company now expects to redeploy about 1.3 billion Danish kroner to 1.5 billion kroner by 2027, an increase from a previous range between 1 billion kroner to 1.3 billion kroner, thanks in part to changes in Lundbeck’s commercial model as a result of the Trintellix divestiture, CFO Joerg Hornstein said on the call.
Besides Vyepti, Otsuka-partnered Rexulti also delivered strong sales growth for Lundbeck, at 28% worldwide, to reach revenue of 3 billion kroner in the second quarter. The increase has been driven by demand for the treatment of Alzheimer’s disease agitation.
But Rexulti recently suffered a setback as an FDA advisory committee cast an overwhelmingly negative vote, saying that the efficacy of the drug’s proposed use alongside sertraline in post-traumatic stress disorder (PTSD) has not been established by existing clinical data.
The problem stemmed from one of two phase 3 trials of Rexulti in the indication missing statistical significance. Still, the near-unanimous thumbs-down came as a bit of a surprise given that several panel members suggested that combo may be effective.
Lundbeck’s R&D chief, Johan Luthman, apparently picked up on the positive sentiment despite the negative vote.
“I think this is an interesting sentiment because we have good data, but not what you regularly like to see for an approval in this space,” he said, referring to the FDA’s typical requirement to have two positive phase 3 trials to grant an antipsychotic approval.
There’s a high medical need in PTSD as the last FDA approval in the field was 23 years ago, Luthman noted on Thursday’s call.
Several advisory committee members suggested that they would be willing to use the Rexulti regimen off-label in patients who do not respond to sertraline, one analyst recalled on the Lundbeck conference call.
Gibbs noted that Rexulti enjoys very good payer access on both the commercial side and on Medicare, and that payer management of utilization doesn’t really get to the indication level. In addition to Alzheimer’s agitation, the drug is currently also approved for major depressive disorder and schizophrenia.
Thanks to strong performance from Vyepti and Rexulti, Lundbeck again raised its full-year growth expectations to a range between 11% to 13% at constant currencies, versus the prior projection of 8% to 11% growth. For the first half of the year, Lundbeck’s total revenue jumped 14% to 12.3 billion kroner ($1.9 billion).