Biohaven Pharmaceuticals has been waging a David-versus-Goliath battle against Big Pharma competitors since launching its new migraine drug Nurtec ODT last year.
Now Goliath is fighting back.
Drug behemoth Eli Lilly announced Tuesday it will conduct a head-to-head study comparing its injectable migraine prevention drug Emgality against the New Haven company’s Nurtec ODT.
The study will be the first head-to-head clinical trial comparing two CGRP (calcitonin gene related peptide) drugs, Eli Lilly said in a news release.
It will examine Lilly’s once-monthly injection against Biohaven’s orally dissolving pill taken every other day in patients with “episodic” migraine, meaning they have fewer than 15 headache days a month.
“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 health care providers,” Ilya Yuffa, president of Lilly Bio-Medicines, said in a statement.
Eli Lilly’s announcement comes two weeks after Biohaven won Food and Drug Administration approval to market its first commercial drug, Nurtec ODT, as a migraine preventative.
The FDA first approved Biohaven’s pill in March 2020 as an acute treatment, meaning patients take it at the start of a headache to thwart an attack.
The most recent approval means doctors can now also instruct patients to take it every other day as needed for prevention.
Biohaven touts it as the only migraine drug on the market that offers patients the convenience of treatment and prevention in one pill.
In a statement responding to Eli Lilly’s announcement Tuesday, Biohaven CEO Vlad Coric said Nurtec is “clearly establishing itself as the leading migraine therapy with a profile that others want to aspire to.”
“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. “We are confident in the advantage that Nurtec ODT offers patients and we continue to work closely with the migraine community and [health care providers] to respond to the needs of patients.”
Nurtec, which brought in $64 million for Biohaven last year, is one of only two oral CGRP drugs on the market. The other is AbbVie’s Ubrelvy.
The treatments are part of a new class of drugs that target CGRP, a protein believed to play a key role in migraine.
Eli Lilly’s injectable drug, which won FDA approval in 2018, binds to the protein, preventing it from attaching to CGRP receptors, while Biohaven’s drug blocks the receptor, according to Eli Lilly.
The pharma giant said its study will look for a 50% reduction in monthly migraine days and enrollment will begin later this year.
Contact Natalie Missakian at news@newhavenbiz.com
