Eli Lilly’s move to begin enrolling for a head-to-head trial, pitching its migraine preventative treatment Emgality (galcanezumab) against Biohaven’s Nurtec (rimegepant), is a bold move as both of these companies are strong players, according to GlobalData. The leading data and analytics company notes that the study is unprecedented because it is the first time that a monoclonal antibody (mAb) drug type that is administered via an injection such as Emgality has been compared against an oral gepant drug type such as Nurtec. Success in this trial will be critical to ensuring the companies’ futures in the field.

Christie Wong, Pharma Analyst at GlobalData comments: “In the past, if you wanted to organize a head-to-head study for a drug such as Emgality, you’d test it against antidepressants, anticonvulsants, or perhaps beta blockers. However, now that gepants have entered the scene, these drugs have increased the competitivity of the migraine market and offer a new challenger to anti-calcitonin gene-related peptide (CGRP) mAbs. Examples of gepants used for migraine prevention are Biohaven’s Nurtec and AbbVie’s Qulipta (atogepant).

“Both Nurtec and Emgality target the same migraine signaling pathway, so demonstrating Emgality’s superiority to Nurtec would put Eli Lilly in a strong position moving forward.”

Key opinion leaders interviewed by GlobalData noted that oral gepants were often favored by primary care physicians and general practitioners due to their convenient administration.

Wong continues: “Emgality requires a neurologist for prescription, whereas Nurtec can be prescribed by general practitioners and is more accessible to patients. This would suggest Nurtec is the obvious winner; however, the drug needs to be taken every other day for migraine prevention. This is a negative because the more complicated a dosing schedule, the less compliant a patient might be, as it may be difficult for patients to track what is a ‘medication day’ and what is a ‘break day’. This risk is lower with Emgality, which has a longer duration of action, being administered on a monthly basis.”

The head-to-head study will be a battle of efficacy—measuring the reduction of monthly migraine days. While Nurtec can relieve acute migraine attacks, whereas Emgality’s ability has not yet been investigated in clinical trials, these are still two strong opponents for migraine prevention.

Wong adds: “Eli Lilly is a strong player in the migraine market, with both acute and preventive products under its belt. But, Biohaven is also strong contender, with a portfolio of small molecule CGRP antagonists.”

Looking to the pipeline, GlobalData notes that the anti-CGRP mAbs (such as Emgality) face even more gepant competition in the near future. AbbVie’s Qulipta received Food and Drug Administration (FDA) approval in September 2021 for preventive treatment in episodic migraine patients, and is being studied in ongoing trials for the prevention of chronic migraine. Furthermore, Biohaven is investigating an oral zavegepant for preventive migraine treatment. GlobalData forecasts that zavegepant will be launched in the US in Q3 2024.