Disease Background
Migraine is a common, disabling, and recurring complex neurological disorder with a genetic component, affecting adults throughout their lifespans. It is characterized by episodic headaches that throb, intensify, and cause or co-occur with nausea, vomiting, and abnormal sensory sensitivities. Migraines can occur without warning or be preceded by symptoms such as fatigue, mood change, and changes in appetite and digestion. Both positive symptoms of migraine, such as geometric patterns or flashing lights, and negative symptoms, such as vision impairment, have gradual onset and resolve completely. Migraine episodes can last from a few hours to a few days.
Latest Key Takeaways
Migraine is a common, disabling, and recurring complex neurological disorder with a genetic component, affecting adults throughout their lifespans. It is characterized by episodic headaches that throb, intensify, and cause or co-occur with nausea, vomiting, and abnormal sensory sensitivities. Migraines can occur without warning or be preceded by symptoms such as fatigue, mood change, and changes in appetite and digestion. Both positive symptoms of migraine, such as geometric patterns or flashing lights, and negative symptoms, such as vision impairment, have gradual onset and resolve completely. Migraine episodes can last from a few hours to a few days.
Latest Key Takeaways
- The publisher estimates that in 2019, there were 554.6 million prevalent cases of migraine in adults aged 20 years and older worldwide, and forecasts that number to increase to 619.8 million prevalent cases by 2028.
- The majority of approved drugs in the migraine space target the serotonin 5-HT family of receptors. Most marketed drugs are administered via the oral route, with a smaller number of products being available in intravenous, intranasal, intramuscular, intradermal, intraarticular, intravesical, rectal, sublingual, oral transmucosal, and subcutaneous formulations.
- Drugs in development for migraine focus on a wide variety of targets. Approximately half of the drugs in development for migraine are administered via the oral route, with the remainder being intranasal, inhaled, subcutaneous, topical, transdermal, sublingual, and oral transmucosal formulations.
- High-impact upcoming events for drugs in the migraine space include topline Phase IIIb trial results for Vyepti, an estimated sNDA PDUFA date for Nurtec ODT, an NDA PDUFA date for atogepant, and topline Phase III results for zavegepant.
- The overall likelihood of approval of a Phase I migraine and other headaches asset is 15.1%, and the average probability a drug advances from Phase III is 90.5%. Drugs, on average, take 7.8 years from Phase I to approval, compared to 10.0 years in the overall neurology space.
- The distribution of clinical trials across Phase I-IV indicates that the majority of trials for migraine have been in the early and mid-phases of development, with 54% of trials in Phase I-II, and 46% in Phase III-IV.
- The US has a substantial lead in the number of migraine clinical trials globally. Germany leads the major European markets, while Japan has the top spot in Asia.
- While clinical performance is important in driving a product’s success in migraine, the overriding differentiation between products, and the CGRP inhibitors in particular, is market access. The CGRP biologics used for migraine prophylaxis are not highly differentiated based on efficacy, and so physicians typically choose brands based on patients’ insurance coverage. In the current market, this has posed a high barrier to the newest entrants such as Vyepti (eptinezumab), but developers will continue to negotiate for formulary placement, which will expand coverage over time.
- The gepants are oral small molecule CGRP receptor antagonists used for abortive migraine treatment. While traditional triptans are still considered the gold-standard treatments for acute migraine and are usually utilized at first line, alternative options are needed for patients who have contraindications, who cannot tolerate side effects, or whose migraine is not well controlled by triptans. Currently, triptans are contraindicated for patients with cardiovascular conditions, which comprises 20% of migraineurs.
- Botox (onabotulinumtoxinA) has had favorable market access positioning given that patients must fail two to three drug classes (including Botox) before the initiation of CGRP biologics. However, payers have recently started to approve the earlier use of CGRP preventives, given mounting supportive evidence and broader labeling covering both chronic and episodic migraine; in comparison, Botox is limited only to those with the chronic form of the disease.
- The first three anti-CGRP antibodies - Aimovig (erenumab), Emgality (galcanezumab), and Ajovy (fremanezumab) - entered the US market in 2018 as preventive treatments, and all have demonstrated similar efficacy in clinical trials, typically reducing the number of headache days of migraineurs by half or more. The CGRP class in general is well tolerated, works relatively quickly, and has proven to be effective in the prevention of both episodic migraine and chronic migraine.
- In addition to clinical needs, focusing on the actions of both the migraine patient and the diagnosing physician remains a significant barrier to effective treatment. The understanding of migraine has evolved significantly over the years and yet there is still a need for consistency between guidelines, which may partly contribute to the underdiagnosis and undertreatment of migraine patients worldwide.
Table of Contents
OVERVIEW
DISEASE BACKGROUND
TREATMENT
NSAIDs
EPIDEMIOLOGY
KEY REGULATORY EVENTS
LICENSING AND ASSET ACQUISITION DEALS
CLINICAL TRIAL LANDSCAPE
DRUG ASSESSMENT MODEL
FUTURE TRENDS
RECENT EVENTS AND ANALYST OPINION
LIST OF FIGURES
LIST OF TABLES
