Eli Lilly initiates first head-to-head study of CGRP migraine drug

The rapid growth of Biohaven's oral migraine drug Nurtec ODT has put tremendous pressure on competitors' migraine preventive drugs
.
Now, the developer of an injectable drug has decided to pass a head-to-head clinical trial to challenge the oral drug
.
Last weekend, Eli Lilly announced the initiation of a phase 4 clinical trial to compare its monthly subcutaneous CGRP migraine drug Emgality with oral tablets Nurtec ODT for the preventive treatment of paroxysmal migraine (EM)
.
The new trial, called Challenge-MIG, plans to enroll about 700 adult patients in the United States, and each patient can participate for up to 6 months
.
In this study, the researchers will measure the proportion of patients whose monthly migraine days are reduced by at least 50% during a 3-month double-blind period
.
At the same time, the researchers will also measure the proportion of patients whose monthly migraine days are reduced by at least 75% and 100% compared with the baseline, as well as the improvement in the quality of life
.
Eli Lilly said that the trial aims to demonstrate superiority and is expected to be completed in the fourth quarter of 2022
.
As Eli Lilly pointed out, in addition to different routes of administration, Emgality and Nurtec ODT have slightly different modes of action
.
Emgality is a monoclonal antibody drug that binds to CGRP protein; and CGRP receptor antagonist (gepant) drugs such as Nurtec ODT target the CGRP receptor
.
Thanks to the FDA's dual approval for acute treatment and preventive treatment of migraine, Nurtec ODT has been on a track of rapid growth
.
The drug's sales in the third quarter increased 46% from the second quarter, reaching 136 million U.
S.
dollars
.
In contrast, Emgality, which entered the market one and a half years earlier than Nurtec ODT, achieved $140 million in sales in the third quarter
.
In addition to revenue growth, Nurtec ODT's market share is also increasing
.
Investment bank Piper Sandler analyst Christopher Raymond recently quoted IQVIA data in a letter to clients, saying that the new brand share of the drug in the United States has surpassed all subcutaneous injection drug options, including Aimovig, which was once the market leader in Amgen
.
In a recent survey of primary care doctors conducted by Piper Sandler, 65% of doctors agreed that Nurtec ODT's dual indications provide convenience and simplicity for patients
.
More importantly, Christopher Raymond also noticed the positive feedback from neurologists on Nurtec ODT.
These doctors are usually more inclined to prescribe injections than primary care doctors
.
Among neurologists, a September survey showed that Nurtec ODT had gained 6% of the episodic migraine prevention market share just 4 months after its label expansion, while Aimovig and Emgality had 11% and 9% respectively.
%
.
In addition, more than half of the neurologists surveyed by Piper Sandler pointed out that between monthly doses, the effect of antibody drugs is weakened
.
Christopher Raymond pointed out in another report that, over time, this dynamic change may prompt the switch from CGRP injections to oral medications in a preventive treatment setting
.
At the same time, injections such as Emgality are now facing more oral competition
.
At the end of September, AbbVie's oral drug Qulipta for the preventive treatment of migraine was approved by the US FDA
.
Before the FDA made its decision, when asked about the drug, the neurologist predicted that Qulipta's approval would get a 0.
8% market share from Emgality's preventive treatment of paroxysmal migraine.

.
Reference source: Eli Lilly, under pressure from Biohaven, launches head-to-head migraine trial between Emgality and Nurtec