Eli Lilly, under pressure from Biohaven, launches head-to-head migraine trial between Emgality and Nurtec

Emgality pen
Eli Lilly is launching a clinical trial pitting its once-monthly injectable CGRP drug Emgality against Biohaven's now Pfizer-partnered daily pill Nurtec for the preventative treatment of episodic migraine. (Eli Lilly)

As Biohaven’s fast-growing Nurtec ODT pressures rival migraine prevention medicines, one injectable player decided to bring the fight directly to the oral drug with a head-to-head clinical trial.

Eli Lilly is launching a phase 4 trial pitting its once-monthly injectable CGRP drug Emgality against Biohaven’s daily pill Nurtec for the preventative treatment of episodic migraine, the Indianapolis pharma unveiled Thursday.

The new trial, dubbed Challenge-MIG, plans to enroll about 700 adults across the U.S., with each individual’s participation lasting up to six months. The study will measure the proportion of patients with at least 50% reduction in monthly migraine days across a three-month double-blind period. Investigators will also measure the proportion of patients who have at least 75% and 100% reductions from baseline, as well as quality of life improvements.

The trial is designed to show superiority, and it’s expected to conclude in the fourth quarter of 2022, a Lilly spokesperson told Fierce Pharma.

RELATED: Biohaven taps Pfizer for global Nurtec push in deal worth up to $1.24B

As Lilly noted, Emgality and Nurtec work slightly different from one another—besides their different administration routes. Emgality, an antibody drug, binds to the CGRP protein, whereas gepants like Nurtec target the CGRP receptor.

Nurtec has been on a fast growth trajectory thanks to its dual FDA approvals for acute treatment and prevention of migraines. Sales from the drug in the third quarter rose 46% from the second quarter to $136 million. By comparison, Emgality, which entered the market a year and a half ahead of Nurtec, brought in $140 million sales in the third quarter.

Aside from revenue growth, Nurtec has also been posting market share gains. The drug’s U.S. new-to-brand share has surpassed all under-the-skin options, including Amgen’s once market-leading Aimovig, Piper Sandler analyst Christopher Raymond recently wrote to clients, citing IQVIA data.

RELATED: Buckle up AbbVie, Amgen: Biohaven's oral CGRP drug is gaining traction in migraine, doctors' survey shows

In a recent survey Piper Sandler conducted among primary care doctors, 65% agreed that Nurtec’s dual indications offer patients convenience and simplicity, even though some worry that patients may run out of medication given quantity limits.

What's more, Raymond also noted positive feedback on Nurtec from neurologists, who tend to prescribe injectables more often than their primary care peers. Among neurologists, a September survey showed that Nurtec had already captured 6% of episodic migraine prevention share just four months after its label expansion, versus 11% for Aimovig and 9% by Emgality.

Further, more than half of the neurologists Piper Sandler polled noted a waning effect of antibody drugs between the monthly doses. Over time, such a dynamic may drive switching from CGRP injectables to oral drugs in the prevention setting, Raymond said in a separate note.

Meanwhile, injectables such as Emgality now face even more oral competition. AbbVie in late September won FDA green light for its oral med Qulipta for preventing migraine. When asked about that drug ahead of its FDA decision, neurologists projected a Qulipta go-ahead would erode 0.8 percentage points of preventive share from Emgality in episodic migraine.

Editor's note: The story has been updated with additional trial info from Eli Lilly.