Eli Lilly Initiates First Head-to-Head Phase 4 Trial Comparing CGRP Migraine Therapies Emgality and Nurtec ODT

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The rapid growth of Biohaven's oral migraine drug Nurtec ODT has put significant pressure on competing migraine preventive medications. Now, the developer of an injectable drug has decided to challenge this oral medication head-to-head through a clinical trial.

Last weekend, Eli Lilly announced the launch of a Phase 4 clinical trial comparing its once-monthly subcutaneous CGRP migraine drug Emgality with oral tablet Nurtec ODT for the preventive treatment of episodic migraine (EM).

The new trial, named Challenge-MIG, plans to enroll approximately 700 adult patients in the United States, with each patient participating for up to six months. In this study, researchers will measure the proportion of patients who experience at least a 50% reduction in monthly migraine days during the three-month double-blind period. Additionally, researchers will assess the proportion of patients with at least a 75% and 100% reduction in monthly migraine days compared to baseline, as well as improvements in quality of life.

Eli Lilly stated that the trial, which aims to demonstrate superiority, is expected to be completed in the fourth quarter of 2022. As Eli Lilly pointed out, apart from different routes of administration, Emgality and Nurtec ODT have slightly different mechanisms of action. Emgality is a monoclonal antibody drug that binds to the CGRP protein, while drugs like Nurtec ODT, which belong to the CGRP receptor antagonist (gepant) class, target the CGRP receptor.

Thanks to the FDA's dual approval for both acute treatment and preventive treatment of migraine, Nurtec ODT has been on a rapid growth track. The drug's sales in the third quarter increased by 46% compared to the second quarter, reaching 136 million U.S. dollars. In contrast, Emgality, which entered the market a year and a half earlier than Nurtec ODT, achieved sales of 140 million U.S. dollars in the third quarter.

In addition to revenue growth, Nurtec ODT's market share is also increasing. Christopher Raymond, an analyst at the investment bank Piper Sandler, recently cited IQVIA data in a letter to clients, stating that the drug's new brand share in the United States has surpassed all subcutaneous injection options, including Amgen's once market-leading Aimovig.

In a recent survey conducted by Piper Sandler among primary care physicians, 65% of doctors agreed that Nurtec ODT's dual indications provide convenience and simplicity for patients. More importantly, Christopher Raymond also noted the positive feedback from neurologists regarding Nurtec ODT, as these specialists are typically more inclined than primary care physicians to prescribe injectable formulations. Among neurologists, a September survey revealed that Nurtec ODT had already captured 6% of the episodic migraine prevention market share just four months after its label expansion, compared to 11% for Aimovig and 9% for Emgality.

Moreover, more than half of the neurologists surveyed by Piper Sandler pointed out that the effect of antibody drugs diminishes between monthly doses. In another report, Christopher Raymond noted that this dynamic change over time may drive a shift from CGRP injectables to oral medications in preventive treatment settings.

Meanwhile, injectables like Emgality now face increasing competition from oral treatments. At the end of September, AbbVie's oral preventive treatment for migraine, Qulipta, received FDA approval in the United States. Prior to the FDA's decision, when asked about the drug, neurologists predicted that the approval of Qulipta would capture 0.8% of the market share from Emgality’s preventive treatment for episodic migraines.

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