CLINICAL TRIALS PROFILE FOR EMGALITY

All Clinical Trials for EMGALITY

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT04271202 ↗	Novel Insight Into Migraine Pathophysiolgy and Galcanezumab Mechanisms of Action	Recruiting	Eli Lilly and Company	Phase 4	2020-07-29	The purpose of this study is to understand better the mechanisms of action of calcitonin gene related peptide (CGRP) targeted monoclonal antibodies in migraine prevention. Specifically, the protocol will allow the investigators to determine whether the main site of action of this novel and recently-approved class of migraine prophylactic drugs act inside or outside the brain and if so, where.
NCT04271202 ↗	Novel Insight Into Migraine Pathophysiolgy and Galcanezumab Mechanisms of Action	Recruiting	Beth Israel Deaconess Medical Center	Phase 4	2020-07-29	The purpose of this study is to understand better the mechanisms of action of calcitonin gene related peptide (CGRP) targeted monoclonal antibodies in migraine prevention. Specifically, the protocol will allow the investigators to determine whether the main site of action of this novel and recently-approved class of migraine prophylactic drugs act inside or outside the brain and if so, where.
NCT04417361 ↗	Galcanezumab for Vestibular Migraine	Recruiting	Eli Lilly and Company	Phase 2	2020-09-18	Vestibular migraine (VM) has been recognized a distinct subtype of migraine that causes dizziness as the predominant symptom. Criteria for diagnosis have been adopted by the Barany Society. Previous epidemiological research from the investigators has shown that VM affects 2.7% of the adult population of the United States. Yet, despite its high prevalence, there is very little data upon which to guide treatment decisions. A Cochrane review in 2015 concluded that there were no placebo controlled trials in VM, and none have been done since then. The investigators recently developed and validated a patient reported outcome tool for VM called VM-PATHI (VM- Patient Assessment Tool and Handicap Inventory). Anecdotal evidence suggests that CGRP antagonists, such as Galcanezumab, may be effective in reducing or eliminating symptoms in VM. Therefore, the investigators propose a pilot study of changes in VM-PATHI scores, comparing active treatment (Galcanezumab) to placebo arms.
NCT04417361 ↗	Galcanezumab for Vestibular Migraine	Recruiting	University of California, San Francisco	Phase 2	2020-09-18	Vestibular migraine (VM) has been recognized a distinct subtype of migraine that causes dizziness as the predominant symptom. Criteria for diagnosis have been adopted by the Barany Society. Previous epidemiological research from the investigators has shown that VM affects 2.7% of the adult population of the United States. Yet, despite its high prevalence, there is very little data upon which to guide treatment decisions. A Cochrane review in 2015 concluded that there were no placebo controlled trials in VM, and none have been done since then. The investigators recently developed and validated a patient reported outcome tool for VM called VM-PATHI (VM- Patient Assessment Tool and Handicap Inventory). Anecdotal evidence suggests that CGRP antagonists, such as Galcanezumab, may be effective in reducing or eliminating symptoms in VM. Therefore, the investigators propose a pilot study of changes in VM-PATHI scores, comparing active treatment (Galcanezumab) to placebo arms.

Clinical Trial Conditions for EMGALITY

Condition Name

Condition Name for EMGALITY
Intervention	Trials
Chronic Migraine	1
Chronic Migraine, Headache	1
Headache, Migraine	1
Vestibular Migraine	1

Condition MeSH

Condition MeSH for EMGALITY
Intervention	Trials
Migraine Disorders	4
Headache	2

Clinical Trial Locations for EMGALITY

Trials by Country

Trials by Country for EMGALITY
Location	Trials
United States	4

Trials by US State

Trials by US State for EMGALITY
Location	Trials
Illinois	2
California	1
Massachusetts	1

Clinical Trial Progress for EMGALITY

Clinical Trial Phase

Clinical Trial Phase for EMGALITY
Clinical Trial Phase	Trials
Phase 4	3
Phase 2	1

Clinical Trial Status

Clinical Trial Status for EMGALITY
Clinical Trial Phase	Trials
Recruiting	3
Not yet recruiting	1

Clinical Trial Sponsors for EMGALITY

Sponsor Name

Sponsor Name for EMGALITY
Sponsor	Trials
Eli Lilly and Company	2
Chicago Headache Center & Research Institute	2
Beth Israel Deaconess Medical Center	1

Sponsor Type

Sponsor Type for EMGALITY
Sponsor	Trials
Other	4
Industry	3

EMGALITY Market Analysis and Financial Projection

EMGALITY: Clinical Trials, Market Analysis, and Projections

Introduction to EMGALITY

EMGALITY, developed by Eli Lilly and Company, is a calcitonin gene-related peptide (CGRP) monoclonal antibody used for the preventive treatment of episodic migraine and cluster headaches in adults. Here, we will delve into the recent clinical trials, market performance, and future projections for this medication.

Clinical Trials: CHALLENGE-MIG Study

One of the most significant recent clinical trials for EMGALITY is the CHALLENGE-MIG study, a 3-month, double-blind, placebo-controlled trial. This study compared the efficacy and safety of EMGALITY with Nurtec ODT (rimegepant) in the prevention of episodic migraine in adults.

Key Findings

• The study involved 580 participants randomized to either EMGALITY (120 mg, with a loading dose of two injections followed by two additional monthly injections) or Nurtec ODT (75 mg, one tablet every other day)[1][4].
• Although EMGALITY did not achieve statistical superiority over Nurtec ODT on the primary endpoint of a 50% reduction in monthly migraine headache days, it performed numerically better on several key secondary endpoints[1][4].

Implications

• The results of the CHALLENGE-MIG trial reinforce EMGALITY's efficacy in migraine prevention, consistent with previous studies. Anne White, Executive Vice President of Eli Lilly and Company and President of Lilly Neuroscience, highlighted that these results demonstrate EMGALITY's ability to improve patients' quality of life with less frequent dosing[4].

Market Performance

Since its approval on September 27, 2018, EMGALITY has shown impressive market performance.

Sales Figures

• In 2019, EMGALITY achieved $163 million in global sales, marking the highest first-year sales for a CGRP antagonist. By 2021, the drug generated $435 million in U.S. sales and $577 million globally[2][5].

Market Reception

• EMGALITY has received coverage from all top three pharmacy benefit managers (PBMs) – Express Scripts, OptumRx, and CVS. Additionally, Lilly offered a 12-month free drug program to facilitate patient access, contributing to its strong market reception[2].

Market Analysis and Projections

Competitive Landscape

• EMGALITY competes in a crowded market with other CGRP antagonists such as Amgen’s Aimovig and Teva’s Ajovy. Despite this competition, EMGALITY has maintained a strong position due to its clinical results and convenient administration via an injection pen[2].

Analyst Forecasts

• Analysts forecast peak sales of EMGALITY to reach $1.27 billion by 2025. This projection is supported by the drug's performance in clinical trials and its growing market share[2].

Eli Lilly's Growth Strategy

• Eli Lilly is focusing on bolstering its sales efforts, particularly with primary care doctors. The company's new-to-brand share is nearly 50%, and it expects continued volume growth through 2025, driven by its newer medications, including EMGALITY[5].

Additional Approvals and Indications

Cluster Headaches

• In addition to its approval for episodic migraine, EMGALITY received approval for the treatment of cluster headaches in adults in 2019. This expanded indication has further broadened its market potential[2].

Expert Insights and Statistics

Clinical Efficacy

• EMGALITY is the only CGRP monoclonal antibody with response rates in the episodic migraine headache population of ≥50%, ≥75%, and 100%[3].

Market Impact

• According to Patrik Jonsson, President of Lilly Bio-Medicines, EMGALITY's success is part of Eli Lilly's broader strategy to drive growth through new launches. The company's newer drugs, including EMGALITY, accounted for nearly half of its global sales in recent quarters[5].

"Emgality produced some impressive clinical results combined with a convenient administration pen and offered patients a 12-month free drug program to speed-up access." - Phil Inc[2]

Future Projections and Growth

Volume Growth

• Eli Lilly expects continued volume growth driven by its newer medications, including EMGALITY. The company's focus on expanding its sales efforts and improving access to the drug is expected to contribute to its top-tier growth through 2025[5].

Market Expansion

• With its strong clinical profile and favorable market reception, EMGALITY is poised to continue its market expansion. The drug's approval for additional indications and its inclusion in various treatment guidelines further support its growth potential.

Key Takeaways

• Clinical Efficacy: EMGALITY has demonstrated robust efficacy in preventing episodic migraine, although it did not achieve statistical superiority over Nurtec ODT in the CHALLENGE-MIG trial.
• Market Performance: The drug has achieved significant sales figures and received broad coverage from major PBMs.
• Analyst Forecasts: Peak sales are projected to reach $1.27 billion by 2025.
• Additional Approvals: EMGALITY is approved for cluster headaches in addition to episodic migraine.
• Growth Strategy: Eli Lilly is focusing on expanding sales efforts and improving patient access to drive continued growth.

FAQs

Q: What is the primary indication for EMGALITY?

A: EMGALITY is primarily indicated for the preventive treatment of episodic migraine in adults.

Q: How does EMGALITY compare to Nurtec ODT in clinical trials?

A: In the CHALLENGE-MIG trial, EMGALITY did not achieve statistical superiority over Nurtec ODT on the primary endpoint but performed numerically better on several key secondary endpoints.

Q: What are the projected peak sales for EMGALITY by 2025?

A: Analysts forecast peak sales of EMGALITY to reach $1.27 billion by 2025.

Q: Is EMGALITY approved for any other conditions besides episodic migraine?

A: Yes, EMGALITY is also approved for the treatment of cluster headaches in adults.

Q: How has EMGALITY been received in the market since its approval?

A: EMGALITY has received strong market reception, with coverage from all top three PBMs and a 12-month free drug program to facilitate patient access.

Sources

1. PR Newswire: "First-Of-Its-Kind Head-to-Head Clinical Trial Reaffirms the Efficacy of Emgality in Episodic Migraine Prevention"[1].
2. Phil Inc: "Migraine - Post Approval Insights"[2].
3. PR Newswire: "Lilly Announces Head-to-Head Study Comparing Once-Monthly Emgality with Every-Other-Day Nurtec ODT for the Preventive Treatment of Migraine"[3].
4. Practical Neurology: "Preliminary Results from CHALLENGE-MIG Trial Comparing Emgality vs. Nurtec ODT for Episodic Migraine Prevention in Adults Reported"[4].
5. FiercePharma: "Lilly gears up for 'top-tier' growth to 2025 thanks to its new launches"[5].