December 18, 2019
Amgen/Novartis’ Aimovig Label Revision and Teva’s Ajovy Autoinjector Delay Clear the Way for Continued Growth of Eli Lilly’s Emgality in the US Migraine Prevention Market, According to Spherix Global Insights
Neurologists and migraine specialists believe that a potential dual acute and preventive migraine indication for Lundbeck’s eptinezumab and Biohaven’s rimegepant could be influential in differentiating the pipeline agents from Allergan’s atogepant and the currently marketed CGRP therapies
EXTON, Pa., December 18, 2019 ― Eli Lilly’s Emgality, the third anti-calcitonin gene-related peptide (CGRP) therapy to the US market for the preventive treatment of migraine, continues to make headway in its efforts to catch up with the class leader, Amgen/Novartis’ Aimovig. Fielded between November 7th and 23rd, data from 102 migraine specialists and neurologists surveyed as part of the ongoing quarterly report series included in Spherix’s RealTime Dynamix™: Migraine Prevention (US) service estimate that Emgality share is up from 28% to 31% as a result of decreased share of Teva’s Ajovy. Emgality is apparently succeeding in differentiating itself from its CGRP competitors by focusing on the brand’s recent approval for episodic cluster headache and driving sustained growth in the episodic migraine prevention segment. One in four physicians report no barriers to their use of Emgality — substantially higher than that seen for the competing CGRP brands. Patients are also playing an important role in Emgality’s success, as physicians are increasingly likely to report recent patient requests for Eli Lilly’s brand — most of which appear to convert to actual prescriptions.
In October 2019, the FDA added a new Warnings and Precautions section to Aimovig’s label related to the risk of serious complications of constipation. Although only one-third of physicians believe that the label revision will make them less willing to prescribe Aimovig, perceptions of the brand exceeding expectations related to safety and tolerability are less positive compared to six months ago. In addition, physicians rate Aimovig lower compared to both Ajovy and Emgality on risk of serious adverse events and tolerability — attributes regarded as extremely important (more so than a year ago) in the decision-making process for preventive therapy selection. Accordingly, tolerability is now second only to insurance coverage as the most influential barrier to greater Aimovig use. In conjunction with these changing perceptual patterns, physician-reported Aimovig share has not increased significantly for either the episodic or chronic migraine segment since the news was released.
With the potential approval of an autoinjector device delayed into the new year, Ajovy remains the only CGRP therapy available exclusively with a prefilled syringe. Data from the current survey point to this delay as having been a substantial obstacle to Ajovy capitalizing on its early lead over Emgality. Compared to both other CGRP brands, Ajovy is rated significantly lower on injector device convenience (or lack thereof), an attribute rated as extremely important in brand selection by more than half of physicians. As we have seen with tolerability and Aimovig, physicians now select inferior injection device second only to insurance coverage as a barrier to increased Ajovy use. In addition, while still not extremely common, more physicians are stating a preference for a different preventive therapy as an Ajovy barrier compared to earlier in the launch, suggesting that, even when an autoinjector device is available, some prescribers may have already established brand loyalty with one of the other CGRP competitors.
Ajovy is the only CGRP therapy to offer dosing frequency flexibility, with both a monthly and a quarterly dosing option. However, Ajovy’s unique quarterly dosing appears to have much less of an influence compared to the lack of an autoinjector device on physicians’ willingness to prescribe, suggesting that launching with an autoinjector would have had a greater impact on leveling the playing field with competitors. That being said, one of the main reasons for selecting the nondifferentiated monthly dosing is the need for three consecutive injections when dosing Ajovy quarterly (more so than efficacy durability concerns). With the availability of an autoinjector device for the quarterly dosing, dosing flexibility may emerge as a more influential driver of Ajovy selection.
Assuming a February 2020 approval for migraine prevention, physicians appear eager to prescribe eptinezumab, a 30-minute infusion CGRP therapy developed by Lundbeck (formerly Alder), especially for patients who have failed Allergan’s Botox or one of the currently marketed subcutaneous CGRP therapies or who are nonadherent to therapy. Consistent with the current profile of patients being treated with Botox and/or CGRPs, physicians estimate the highest eptinezumab candidate pool among patients with high frequency episodic migraine or chronic migraine. Although divided on the impact eptinezumab will ultimately have on their preventive therapy switch rate among chronic patients, physicians are clearly more likely to agree than disagree that the 100% bioavailability by the end of the infusion will be an effective differentiator in the CGRP class.
Eptinezumab and Biohaven’s rimegepant, an oral CGRP therapy, are both in clinical development for a dual acute and preventive migraine indication, although, unlike eptinezumab, rimegepant will likely be first launched for the acute treatment of migraine. Approval for such a dual indication would provide a substantial point of differentiation for these agents over Allergan’s pipeline CGRP, atogepant, as well as the currently marketed CGRP therapies. The majority of physicians agree that they would be more willing to prescribe a novel CGRP therapy approved with a dual indication. With almost half of physicians agreeing that eptinezumab will be effective as an acute therapy, Lundbeck would most likely benefit by positioning the infusion CGRP as an acute option for patients who frequently use the ER or urgent care or who are known to overuse acute medications. However, the availability of a dual indication may ultimately have a greater impact on rimegepant, due to its oral dosing profile, higher physician awareness of the dual indication clinical development program, and an acute migraine commercial launch which could predate eptinezumab launch for migraine prevention by three months. Spherix will track both launches over the first 18 months of commercial availability for migraine prevention to benchmark the influence of migraine label expansions on brand prescribing patterns and perceptions.
About RealTime Dynamix™
RealTime Dynamix™: Migraine Prevention (US) is an independent service providing strategic guidance through rapid and comprehensive quarterly reports, which include market trending, launch tracking, and a fresh infusion of unique content with each wave. The 7th wave of research will publish in March 2020.
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 immunology, nephrology, and neurology markets.
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