It’s good news for Migraine patients as Eli Lilly and Company’s Emgality™ (galcanezumab-gnlm) became the third new CGRP monoclonal antibody approved by the FDA for Migraine Prevention in Adults. With Emgality™ approved for Migraine prevention, patients now have choiced of preventive treatments that were developed specifically for Migraine prevention.
Eli Lilly and Company announced on September 27, 2018, that the U.S. Food and Drug Administration (FDA) has approved Emgality™ (galcanezumab-gnlm) 120 mg injection for the preventive treatment of Migraine in adults. Emgality offers a once-monthly, self-administered, subcutaneous injection. Emgality is a humanized CGRP antagonist monoclonal antibody and is contraindicated in patients with serious hypersensitivity to galcanezumab-gnlm or to any of the excipients.
Emgality will be available to patients shortly, through their local pharmacies. Patients with commercial insurance are candidates to receive Emgality for up to 12 months free as part of Lilly’s patient support program (governmental beneficiaries excluded; subject to terms and conditions).
Christi Shaw, president, Lilly Bio-Medicines, commented:
“Despite the devastating impact of migraine, only about 10 percent of people living with the disease are currently taking a preventive treatment. For more than two decades, Lilly has recognized this unmet need, and we have worked tirelessly to develop a new option specifically designed for the prevention of migraine. With this approval, we are thrilled to offer a preventive treatment option to adults living with this disease.”
“We know the impact high deductible and rising out-of-pocket costs have on families, and Lilly takes seriously our role in ensuring affordable access to Emgality for as many patients as possible. Lilly’s choice to provide Emgality for up to 12 months free to all eligible patients with commercial insurance underscores our 25-year commitment to recognizing and addressing the need experienced by those with migraine.”¹
Jill Dehlin, chair, Patient Leadership Council, National Headache Foundation, commented:
“I have lived with migraine for more than 30 years, and I have experienced firsthand the impact it has on your life, including the ability to perform daily activities. Those of us living with migraine have spent years hoping for new treatment options, and I am thankful for the efforts by researchers, investigators and clinical trial patients who have helped make this possible.”¹
Emgality’s performance in clinical trials
The efficacy and safety of Emgality was demonstrated in two Phase 3 clinical trials in patients with episodic Migraine (EVOLVE-1 and EVOLVE-2) and one Phase 3 clinical trial in patients with chronic Migraine (REGAIN).
EVOLVE-1 and EVOLVE-2 were six-month, double-blind, placebo-controlled studies that enrolled adult patients with episodic Migraine (defined as 4-14 migraine headache days [MHDs] per month). REGAIN was a three-month, double-blind, placebo-controlled study that enrolled adult patients with chronic Migraine (defined as at least 15 headache days per month with at least 8 MHDs per month). In all three studies, patients were randomized to receive once-monthly placebo, Emgality 120 mg after an initial loading dose of 240 mg, or Emgality 240 mg. The primary endpoint was the mean change from baseline in the number of monthly MHDs over the double-blind treatment period in the intent-to-treat study population.
EVOLVE-1:
- Mean change from baseline (days): -4.7 days (N=210) for Emgality 120 mg compared to -2.8 days (N=425) for placebo
- At least a 50 percent reduction in Migraine days in any given month on average (% responders): 62% (N=210) for Emgality 120 mg compared to 39% (N=425) for placebo
- At least a 75 percent reduction in Migraine days in any given month on average (% responders): 39% (N=210) for Emgality 120 mg compared to 19% (N=425) for placebo
- 100 percent reduction in Migraine days in any given month on average (% responders): 16% (N=210) for Emgality 120 mg compared to 6% (N=425) for placebo
EVOLVE-2:
- Mean change from baseline (days): -4.3 days (N=226) for Emgality 120 mg compared to -2.3 days (N=450) for placebo
- At least a 50 percent reduction in Migraine days in any given month on average (% responders): 59% (N=226) for Emgality 120 mg compared to 36% (N=450) for placebo
- At least a 75 percent reduction in Migraine days in any given month on average (% responders): 34% (N=226) for Emgality 120 mg compared to 18% (N=450) for placebo
- 100 percent reduction in Migraine days in any given month on average (% responders): 12% (N=226) for Emgality 120 mg compared to 6% (N=450) for placebo
REGAIN:
- Mean change from baseline (days): -4.8 days (N=273) for Emgality 120 mg compared to -2.7 days (N=538) for placebo
- At least a 50 percent reduction in Migraine days in any given month on average (% responders): 28% (N=273) for Emgality 120 mg compared to 15% (N=538) for placebo
- Emgality 120 mg was not significantly better than placebo for the proportion of patients with 75% and 100% reduction from baseline in the number of monthly Migraine days over the three-month treatment period.
Emgality dosing
Emgality is available in auto-injector pens or prefilled syringes for subcutaneous injection.
- The recommended dose for Emgality is 240 mg (two subcutaneous injections of 120 mg each, on the same day, one after the other) once as a loading dose, followed by monthly doses of 120 mg injected subcutaneously.
- Some doctors will have loading dose samples available in their offices. Their patients can use their loading dose in the doctor’s office and take a prescription for one injection per month maintenance to their pharmacy.
Adverse reactions
The safety of Emgality was evaluated in three clinical trials that included more than 2,500 patients. Hypersensitivity reactions (e.g., rash, urticaria and dyspnea) have been reported with Emgality in clinical studies, can occur days after administration and may be prolonged. The most common adverse reactions (incidence 2 percent or more for Emgality and at least 2 percent greater than placebo) associated with Emgality treatment (120 mg vs. placebo) were injection site reactions (18% vs. 13%).
Emgality pricing
The pricing of Emgality is in line with that of Aimovig and Ajovy, with a U.S. list price of $575 once-monthly, or $6,900 annually.
Emgality savings card
Lilly is offering Emgality free to patients with commercial insurance for up to 12 months with their savings card. Here’s a brief description of their terms and conditions:
Offer good for up to 12 months until 12/31/2020 if healthcare provider submits the prior authorization form or letter of medical necessity, if required, to the patient’s insurance provider. $0 monthly offer for commercially insured with insurance provider coverage, subject to wholesale acquisition cost plus usual and customary pharmacy charges and a separate $4900 maximum annual cap. $0 monthly offer for commercially insured without insurance provider coverage, subject to monthly and annual cap of wholesale acquisition cost plus usual and customary pharmacy charges.
Offer void where prohibited by law. This offer is invalid for patients without commercial insurance coverage or those whose prescription claims are eligible to be reimbursed, in whole or in part, by any governmental program, including, without limitation, Medicaid, Medicare, Medicare Part D, Medigap, DOD, VA, TRICARE/CHAMPUS, or any state patient or pharmaceutical assistance program.
You can get full details and download a savings card from the Emgality web site.
Here’s a video about how to get started with Emgality:
This interesting video includes conversation about what CGRP is and how researchers became interested in exploring its implications for Migraine treatment:
Summary and implications for patients
With Emgality™ approved for Migraine prevention, there are now three treatments available that were developed specifically for Migraine. This is the biggest step forward in Migraine treatment since Imitrex was introduced in 1992 and the triptan family was launched.
Patients who have started treatment with Aimovig or Ajovy should not stop them to try Emgality before giving them a fair trial. When speaking with Migraine experts, some have told me that any of these medications should be tried for six months for a fair trial; some have said three months.
Targeting CGRP for Migraine treatment isn’t stopping with Migraine prevention. There are acute treatments in development, some of which may be approved by the FDA fairly soon.
For all of the progress we’re seeing, it’s important to know that we still need more research funding. Part of the reason it’s been so difficult for Migraine treatments to be developed is that the cause and pathophysiology of Migraine disease are still not fully understood.
As a side note, I would encourage people such as Christi Shaw, president, Lilly Bio-Medicines, to check their facts before speaking about Migraine and their products. In some of her statements, Shaw referred to the 30 million Americans with Migraine. That number is far outdated. There are now more than 39 million Americans with Migraine.
Sources:
Press Release. “Lilly’s Emgality™(galcanezumab-gnlm) Receives U.S. FDA Approval for the Preventive Treatment of Migraine in Adults.” Eli Lilly and Company. Indianapolis. September 27, 2018.