EXTON, Pa., Sept. 23, 2021 /PRNewswire/ -- Just weeks after the FDA approval of Nurtec ODT's label expansion for the preventive treatment of episodic migraine, Eli Lilly announced initiation of a head-to-head Phase IV trial comparing their Emgality to Biohaven's gepant in patients with episodic migraine by the end of this year. With all metrics pointing to extremely strong uptake of Nurtec ODT in the prevention segment, Eli Lilly is looking to proactively defend their brand's opportunity within the market, while also adding to the body of scientific evidence supporting the role of calcitonin gene-related peptide (CGRP) in migraine.

In the third annual audit included in Spherix's RealWorld Dynamix™: Preventive Treatment in Migraine (US) service, 221 neurologists and migraine specialists provided data on 1,013 patients. The patients included in the study were prescribed Nurtec ODT, Emgality, Amgen's Aimovig, Teva's Ajovy, Lundbeck's Vyepti, or AbbVie's (formerly Allergan, an AbbVie company) Botox for the preventive treatment of migraine no more than three months prior to the July 2021 fielding.

According to the chart audit data, Nurtec ODT-treated patients were almost twice as likely to be diagnosed with low frequency episodic migraine – in line with the gepant's approved prevention indication for episodic migraine. In comparison, close to one-third of patients recently prescribed Emgality were diagnosed with chronic migraine.

Consistent with this pattern, Emgality-treated patients were more likely to have typically severe migraine attacks and to have a 21+ score on the Migraine Disability Assessment (MIDAS) questionnaire, reflecting severe or very severe migraine-related disability at the time of the brand selection. Indeed, almost two out of five patients were considered occupationally disabled due to migraine when prescribed Emgality.

The decision to make a change to the patient's preventive therapy regimen, whether by initiating preventive treatment for the first time or by prescribing a new option, was driven by efficacy needs in the majority of audited cases. The leading efficacy-related factor was prolonged or increased duration of migraine attacks when prescribed Emgality and persistently high or worsening migraine severity when prescribed Nurtec ODT. Reasons other than efficacy that were relevant for regimen changes toward Emgality included patient request, tolerability, and sample availability. 

Likely benefiting from broad use as an acute therapy, Nurtec ODT is currently being prescribed as an earlier-line preventive therapy compared to Emgality. The majority of patients prescribed Nurtec ODT had failed at most one prior therapy, whereas more than half of patients were prescribed Emgality after two or more prior preventive therapy failures. Among those who discontinued a therapy, topiramate and/or an antidepressant were the most likely prior therapies for both brands.

While contributing physicians were substantially more likely to agree that the responder rates of the CGRP monoclonal antibodies (i.e., Emgality) versus that of Nurtec ODT are superior to topiramate or Botox, efficacy expectations were key to decisions to prescribe the gepant.

Nurtec ODT was most commonly prescribed due to a desire for sustained efficacy, speed of efficacy onset, and ≥50% responder rate. Although Nurtec ODT represents the first oral CGRP antagonist, attributes related to its dosing profile did not break the top five most common reasons for prescribing. In comparison, favorable tolerability profile and preferred autoinjector were among the most common reasons for deciding to prescribe Emgality.

Suggesting strong competitive pressure within the prevention segment, Emgality lost more than half of the brand's possible new prescription opportunities to other brands. In comparison, Nurtec ODT tends to emerge successful when up against a likely alternative option during the therapy selection process. When competing directly with Emgality, preferred dosing formulation and better convenience were central to Nurtec ODT winning the new prescription opportunity.

However, in the end, it is Aimovig and Botox (and not Emgality) that appear to be Nurtec ODT's toughest competitors, with monthly migraine day reduction expectations and patient requests driving those brands' respective wins over the new kid on the block. With Nurtec ODT approved for episodic migraine and Botox for chronic migraine, it's expected that AbbVie's focus is on atogepant – the potentially second-to-segment gepant assuming a positive PDUFA later this month for the preventive treatment of migraine.

While Aimovig and Emgality antagonize CGRP through different mechanisms, positive outcomes from Eli Lilly's planned head-to-head trial demonstrating efficacy superiority to Nurtec ODT could help Amgen buffer future competition from Nurtec ODT and atogepant.

About RealWorld Dynamix™
RealWorld Dynamix™ is an independent, data-driven service unveiling real patient management patterns through rigorous analysis of large-scale patient chart audits. Insights reveal the "why" behind treatment decisions, include year over year trending to quantify key aspects of market evolution, and integrate specialists' attitudinal & demographic data to highlight differences between stated and actual treatment patterns.

The 2021 audit is the third annual edition included in the RealWorld Dynamix™: Preventive Treatment in Migraine (US) service. Learn more about our services here.

About Spherix Global Insights
Spherix Global Insights is a hyper-focused market intelligence firm that leverages our own independent data and expertise to provide strategic guidance, so biopharma stakeholders make decisions with confidence. We specialize in select dermatology, gastroenterology, nephrology, neurology, and rheumatology markets.

All company, brand or product names in this document are trademarks of their respective holders.

For more information contact:
Kristen Henn, Business Development Manager
Email: [email protected]
www.spherixglobalinsights.com

SOURCE Spherix Global Insights

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