H. Lundbeck A/S’ antibody-based migraine therapy, Vyepti (eptinezumab-jjmr), received FDA approval as the first and only intravenous preventive treatment for adults.

The approval follows last fall’s acquisition of Alder Biopharmaceuticals Inc. by Lundbeck for up to $1.95 billion net of cash, which came with Alder’s lead drug candidate, eptinezumab. The deal was touted by Lundbeck at the time is “the biggest deal ever done by a Danish pharmaceuticals company.”

Vyepti is the fourth antibody targeting calcitonin gene-related peptide (CGRP) to reach the market and comes with an unconventional dosing schedule: infused 30 minutes every three months while the other currently approved antibodies are subcutaneously administered. The recommended dosage is 100 mg every three months.

Vyepti becomes available in April. While the price was not revealed, SVB Leerink’s Marc Goodman expects annual costs of between $3,000 to $5,000. Last fall, J.P. Morgan analysts forecast peak sales of about $800 million in migraine prevention for eptinezumab. Lundbeck has not issued any sales forecasts, but its ambitions go beyond that estimate to blockbuster status. The anti-CGRP drugs market is forecast to grow to $7 billion by 2027.

A potential competitor, also with blockbuster potential, is Biohaven Pharmaceutical Holding Co. Ltd.’s rimegepant, which is up for FDA review this quarter. Rimegepant is one of 11 candidates on the Cortellis Drug to Watch list, which showcases drug entering the market this year with the potential to hit annual sales of $1 billion each within the next five years.

Rimegepant’s NDA, using a priority review voucher, was filed in the U.S. in the second quarter of 2019 seeking approval to treat acute migraine. Worldwide rights were acquired by Biohaven in 2016 from Bristol-Myers Squibb Co. If approved, sales are expected to rise to $1.03 billion in 2024, according to Cortellis analysis, although rimegepant would compete with Ubrelvy and orals from other classes, such as the 5-HT 1f agonist Reyvow (lasmiditan, Eli Lilly and Co.), approved by the FDA in October 2019. Other potential competitors include Trokendi XR (topiramate, Supernus Pharmaceuticals Inc.) and Botox (botulinum toxin type A, Allergan plc).

Vyepti’s approval stems from two phase III studies, PROMISE-1 for treating episodic migraine and PROMISE-2 for chronic migraine. Both trials hit their respective primary endpoints, a decrease in the mean monthly migraine days (MMD) over months one through three. Both studies also showed sustained reductions of mean MMDs through the second dose, in month six. The program found a treatment benefit over placebo as early as day one following the infusion. The percentage of patients with migraine was lower than the placebo group for the majority of the first seven days following treatment.

Vyepti was approved on its target PDUFA date, Feb. 21. The company stock, traded on the Copenhagen Stock Exchange under LUN, drifted about 4% lower on Monday.

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