When the FDA awarded Biohaven Pharmaceuticals’ migraine med Nurtec ODT with a second indication last month, the company paraded the drug as the only option to both prevent and treat migraines. Now, Eli Lilly wants to pin its rival antibody against Biohaven’s pill as a prevention option for lower-frequency migraine patients.
The Indianapolis-based drugmaker on Tuesday said it will study its monthly injectable monoclonal antibody Emgality against Biohaven’s every-other-day oral option to help reduce attacks in patients with episodic migraines, or those who experience fewer than 15 days of headaches per month.
The phase 4 multi-site study will be the first head-to-head between the two drugs and is set to start enrolling patients later this year, Lilly said. The primary endpoint will be a 50% reduction in the number of headache days patients experience per month versus Nurtec ODT.
Both drugs are designed to target calcitonin gene-related peptide (CGRP), a protein in the brain that’s thought to play a key role in migraines, Lilly said. However, Lilly’s drug binds to CGRP to prevent it from attaching to receptors, while Biohaven’s Nurtec ODT blocks the receptor.
Tina Oakes, Lilly’s lead study developer and senior research advisor of migraine, noted that this will be the first study between the two methods for migraine patients and could help fill a gap in the information both clinicians and providers need when deciding on treatments.
“That’s another area that we hope this study will elucidate key differences between those mechanisms,” Oakes said in an interview.
Nurtec ODT is the only drug that boasts FDA approvals to prevent and immediately treat migraines. Meanwhile, Emgality has the agency’s nod to prevent migraines and episodic cluster headaches in adults, a form of headache that produces extreme pain and tends to occur in clusters, often at the same time of the day, for several weeks to months, according to the FDA.
In response to Lilly's head-to-head study, Biohaven CEO Vlad Coric, M.D., said Tuesday that Nurtec ODT is "clearly establishing" itself as a leading CGRP medicine and the company is confident in its advantages.
"In our opinion, this study by Lilly is a competitive move by a company with an injectable drug to try to hold market share despite shifting sentiment to oral CGRP targeting drugs now being approved for the prevention of migraines," Coric said in an emailed statement.
When Biohaven’s 75-mg pill scored its second indication in late May, Coric touted the drug’s convenience in an interview with Fierce Pharma. Instead of the need for physicians to prescribe different migraine treatments, patients could simply take Nurtec ODT for both, Coric said.
Still, Coric noted that the mAb options are better relegated for patients with high-frequency migraines, rather than episodic patients. However, Lilly doesn’t see it that way.
Oakes noted that Emgality is the only mAb that boasts a 50%, 75% and 100% reduction in monthly migraine headache days for episodic patients in its FDA label, which includes two trials in the shorter-term migraine group. Meanwhile, the company stands by the convenience of a once-monthly injection compared to an oral option, Oakes added.
“We don’t believe that one size fits all," Oakes said.
Both Lilly and Biohaven’s treatments face other competitors in the migraine market. The FDA is reviewing an oral drug from AbbVie, known as atogepant, for the preventive treatment of migraines. That pill is taken daily. AbbVie's Ubrelvy won FDA approval in late 2019 as an acute treatment option.
Meanwhile, injectable monoclonal antibodies such as Amgen’s Aimovig and Teva Pharmaceuticals’ Ajovy have been approved in the preventive space for years. After picking up two new patents on Ajovy, Teva recently sued Eli Lilly for alleged patent infringement.
Editor's note: This story has been updated with comments from Tina Oakes, Lilly’s lead study developer and senior research advisor of migraine.