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.
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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.
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.
When Biohaven’s 75-mg pill scored its second indication in late May, CEO Vlad Coric, M.D., 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.
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Still, Coric noted that the mAb options are better relegated for patients with high-frequency migraines, rather than episodic patients. For its part, Lilly argues the upcoming head-to-head results will determine how clinicians and patients “make more informed treatment decisions on the path to more migraine-free days.”
“We are confident in Emgality’s efficacy profile and that our head-to-head clinical trial against Nurtec ODT will yield valuable insights for patients and their healthcare providers,” Ilya Yuffa, president of Lilly Bio-Medicines, said in a statement.
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.
