When the Biohaven-owned oral migraine drug Nurtec ODT started steaming ahead in 2021, Eli Lilly sought to blunt the rival’s momentum with a trial designed to show its injectable Emgality works better at preventing migraines.
That project has now fallen through.
Emgality didn’t outdo Pfizer’s Nurtec in the prevention of episodic migraines in a head-to-head trial, Lilly said Friday. The phase 4 study, dubbed CHALLENGE-MIG, found Emgality wasn’t better than Nurtec on an endpoint that examined the percentage of patients who achieved at least a 50% reduction in monthly headache days after three months of treatment.
The response rates between the two drugs were similar, Lilly said. But on some secondary endpoints, Lilly said Emgality did numerically better than its oral rival. The different expressions could indicate that Emgality might have come slightly below Nurtec on the primary endpoint. Detailed data will be presented at a medical meeting, Lilly added.
Nurtec won its original FDA nod for the acute treatment of migraines in 2020 and added the prevention indication in 2021. That broad label and oral formulation were considered advantages over injectables such as Emgality, which doesn’t have the FDA approval to treat migraines as they happen.
Nurtec’s fast growth and strong reception among doctors prompted Pfizer to acquire Biohaven’s migraine portfolio for $11.6 billion last year.
Emgality could have gained an edge over Nurtec if it showed superior efficacy. After all, the drug's direct delivery into the circulatory system is theoretically a more potent method than having to go through the digestive system via an oral drug. But that theory doesn’t seem to ring true in the head-to-head comparison, at least based on findings from the CHALLENGE-MIG study.
Both Nurtec and Emgality belong to the anti-CGRP drug class, which now includes eight members, including seven for the prevention of migraines. Besides the injectables and oral meds, Lundbeck’s Vyepti comes as an infusion, and Pfizer in March won an FDA go-ahead for legacy Biohaven’s nasal spray Zavzpret.
Both drugs have delivered weak sales in the past several months, starting in the last quarter of 2022. Despite a strong launch out of the gate, Nurtec’s sales came in 27% and 28% below Wall Street’s expectations in the fourth quarter of 2022 and the first quarter of 2023, respectively. The drug generated $211 million and $167 million during those quarters, respectively.
During the same periods, Lilly's Emgality brought in $176 million and $154 million, respectively, both below analysts’ previous estimates.
Pricing pressures have played a part in the drugs’ lackluster showing. As for the quarter-over-quarter decline, Pfizer blamed it on the annual copay reset at the beginning of the year.
Meanwhile, AbbVie’s oral duo of Qulipta and Ubrelvy has also caused some troubles for Nurtec. The two AbbVie meds together delivered $218 million sales in the first quarter of this year.