Third in Class of Migraine Prevention Medications Receives FDA Approval, Introducing Emgality (galcanezumab-gnlm)

Emgality (galcanezumab-gnlm) became the third in its class of CGRP drugs to receive Food and Drug Administration approval on Thursday, September 27, 2018. Emgality is a product of Eli Lily and Company.

“Despite the impact of migraine, only about 10 percent of people living with the disease are currently taking a preventative Crowds of peopletreatment,” said Christi Shaw, president. Lilly Bio-Medicines. “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 preventative treatment option to adults living with this disease.”

Though it is quickly becoming a saturated market with Aimovig and AjovyAjovy being previously approved and several more awaiting approval, Lilly believes that Emgality will eventually lead the way in sales of CGRP drugs – in part due to its success in Phase 3 clinical trials and in part to its Emgality Saving Cards Program.

What is Emgality?

Emgality is a CGRP antagonist, a humanized monoclonal antibody similar to Ajovy, that attaches to the calcitonin gene-related peptide (CGRP) which prevents it from binding to the CGRP receptors in the body. This, in turn, is believed to prevent the cascading symptoms of a migraine headache attack.

Emgality is a self injected medication (pen or pre-filled syringe) given at 120mg monthly after a loading dose of 240mg (given as two 120mg injections).

Emgality Proven in Three Clinical Trials

Research ImageEmgality showed much success in three Phase 3 clinical trials, EVLOVE 1, EVOLVE 2, and REGAIN, involving around 2500 patients in total.

EVOLVE 1 and EVOLVE 2 were six month studies of participants who suffered from episodic migraine (4 to 8 migraines per month). They were both double-blind, placebo controlled studies.

EVLOVE 1 resulted in a mean reduction of migraines by -4.7 days for Emgality and -2.8 days for the placebo. 62% of participants receiving Emgality reported a decrease in migraine days of 50% or more, as opposed to 39% of patients receiving the placebo, and 75% of patients receiving Emgality reported a decrease of 75% or more as opposed to 19% of those receiving the placebo. 16% of participants on Emgality reporting a reduction of 100% of their migraines as opposed to 6% of those on the placebo.

EVLOVE 2 had similar results, with a mean reduction of migraines by -4.3 days. Of those receiving Emgality, 59% reported a reduction of 50% or more, 34% reported a reduction of 75% or more and 12% reported a reduction of 100% as opposed to 36%, 18% and 6%, respectively, of those receiving the placebo.

Patients with chronic migraine (CM) were followed for three months in the REGAIN study. Chronic migraine is the occurrence of more than 8 headaches resulting in 15 or more days impacted by migraine. The baseline of those receiving Emgality was -4.8 days, as opposed to -2.7 in the placebo. Of participants receiving Emgality, 28% reported a 50% or more decrease in headache days, as opposed to 15% of those receiving the placebo. The results of those who reported 75% to 100% of headache days was not significantly more than those receiving the placebo.

Contraindications and Warnings

As with any medication, a small percentage of people (less than or equal to 2% in studies for Emgality) are going to experience hypersensitivity reactions to medication. Hypersensitivity reactions include rash, urticaria (hives) and dyspneaWarning Sign (difficulty breathing). These reactions can develop from hours to days after injection.

Eli Lilly states that anyone experiencing a hypersensitivity reaction should discontinue use of Emgality and should immediately seek the proper medical treatment, as these reactions can be prolonged in the use of monthly medications.

Anyone with a known hypersensitivity reaction to galcanezumb-gnlm or any of its excipients should not take Emgality.

Adverse reactions that were observed during the trials (18% for Emgality v 13% for placebo) included injection site reactions (pain, soreness or swelling at the injection site). Anyone experiencing other reactions to Emgality are encouraged to report them to their doctor as well as to the FDA.

Availability of Emgality

Emgality is expected to be available in local pharmacies in a short period of time after its approval. It will be available in self injector pens or pre-filled syringes that the patient can administer to themselves at home. Nursing instruction on how to give injections is available by contacting Eli Lilly (see below).

A loading dose of 240mg (two doses of the regular 120mg doses) is recommended at the beginning of treatment, followed by one dose of 120mg each month.

Emgality Saving Card Program

Savings Piggy BankOne of the ways that Eli Lilly and Company believes that it will come out of a saturated market as the leader in CGRP sales is the results in their studies. The other reason is its savings program, the Emgality Saving Card, which gives up to 12 months of Emgality to patients with commercial insurance for as little as $0 copay.

You read that right – a $0 copay for up to 12 months!

The program is available in the United States and Puerto Rico. Patients with federal or state funded insurance are NOT eligible for this program. These programs include, but are not limited to Medicaid, Medicare, Medicare Part D, Tri-Care/Campus, VA or any state funded pharmacy programs.

“We know the impact of high deductibles 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, says Shaw. “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.”

In MA the card expires the earlier of

  • the date on the card, December 31, 2020
  • the date an AB-rated generic becomes available
  • June 30,2019 in absence of a change in MA law

In CA the card expires the earlier of

  • The date on the card, December 31, 2020
  • The date an FDA equivalent or over-the-counter medication with the same active ingredients becomes available

The Card is not health insurance. This promotion ends for everyone on December 31,2020, and can be terminated, rescinded, revoked or amended by Eli Lilly and Company without notice.

The European Union is Following the FDA’s Lead

In a move not preceded with the previous two CGRP drugs, Aimovig and Ajovy, on September 21, 2018, a full six days before its FDA approval, the European Medical Agency (EMA) Committee for Medicinal Products for Human Use (CMPHU) issued a positive opinion on Emgality which has been forwarded to the European Commission which gives final approval of medications for the European Union.

Who is Eli Lilly?

Eli Lilly is described as a global healthcare leader that “unites caring discovery to make life better for people around the Light Bulb in Idea Bubbleworld.” Eli Lilly and company was founded by a single man who was committed to creating high quality medications to meet real needs of the people.

Based in Indianapolis, Indiana, Lilly remains true today to the same vision and philosophies that the company was founded upon. Employees around the world strive to discover and to bring life-changing medications to meet the real, unfulfilled needs of people everywhere.

Lilly’s employees are also active in philanthropic ventures and log thousands of volunteer hours every year.

Wrap Up

Migraine is the World Health Organization’s 7th leading cause of disability. Over 37 million people around the United States suffer from the debilitating effects of migraine headaches. Of those, only around 10% of those who could benefit from preventative treatment, actually receive them. This is by-in-large due to the unpleasant, unwanted side effects of the medications used in the prevention of migraine before May of this year.

CGRP drugs bring new hope to those suffering migraines. Not only have there been minimal side effects and few hypersensitivity reactions to them, they are the first class of drug to actually target what is believed to be a cause of the cascading pain and other symptoms of migraine headache attacks. Before CGRP drugs, medications for the treatment and prevention of migraine only addressed the symptoms and preventing the symptoms

In receiving FDA approval and bringing Emgality to the marketplace, Eli Lilly brings to the table not only a century of experience, but also an unprecedented saving program for those who meet the criteria for being prescribed the medication – up to 12 months at as low as $0. The good news may not be just for the US. Emgality is also being considered for approval by the European Union.

“I have lived with migraine for more than 30 years, and I have experienced firsthand the impact it has on your life, including your ability to perform daily activities,” said Jill Dehlin, chair, Patient leadership Council, National Headache Foundation. “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.”

For More Information

As I stated in previous articles, this would be a great time to schedule an appointment to speak to your doctor about Emgality. While your doctor may not have all the information available today, he/she likely will by the time your appointment rolls around.

For more information on the Emgality Savings Card Program, or for any questions you may have before meeting with your doctor, contact the Eli Lilly Answer Center in one of the following ways:

  • 1-800 LILLY RX (1-800-545-5979)
  • 1-800 EMGALITY (1-800-364-2548)
  • www.lilly.com
  • Text “INFO” to 54559

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