FDA Approved Emgality Offers New Hope For Migraine Prevention

PainRelief.com Interview with:
Gudarz Davar, M.D., Vice President
Neuroscience Platform Leader
Eli Lilly and Company

PainRelief.com: What is the background for this announcement?  How big a problem is migraine in the US?  Who is primarily affected? 

Response: Migraine is a disabling, neurologic disease that affects more than 30 million American adults. According to the Medical Expenditures Panel Survey, the total unadjusted cost associated with migraine in the U.S. is estimated to be as high as $56 billion annually. People with migraine can miss out on significant moments in their lives—birthdays and anniversaries—and there remains an unmet need for treatment options that can help patients achieve significant reductions in the overall frequency of migraine attacks.

Emgality (galcanezumab-gnlm) was approved by the FDA on Thursday, September 27, for the preventive treatment of migraine in adults. Emgality is a humanized monoclonal antibody indicated for the preventive treatment of migraine in adults that binds to CGRP ligand and blocks its binding to the receptor, which is believed to play a role in migraine. It is offered as a self-administered, once-monthly subcutaneous injection. Emgality offers new hope to people living with migraine as one of the first medicines developed specifically for the prevention of migraine.

PainRelief.com: How does Emgality™ differ from other medications for migraine relief?

Response: First, Lilly recognizes that choice is critical in this disease state and all therapeutic categories and supports the need for multiple treatment options for adults with migraine. From a clinical perspective, we did not study Emgality relative to other CGRP therapies or with approved treatments for migraine. We therefore cannot make direct comparisons between Emgality and other treatments.

It is our hope that Emgality will be seen as the treatment of choice for patients and physicians, as it can provide migraine-free days for adults with migraine. Data from Phase 3 episodic migraine trials showed that in any given month on average:

  • More than two-thirds of patients had at least a 50% reduction in migraine headache days a month.
  • One-third of patients treated with Emgality also had at least a 75% reduction in migraine headache days.
  • 1 in 7 patients treated with Emgality experienced migraine freedom.

In separate clinical studies, 96% of patients also found the pen “easy-to-use” and 95% were confident in their ability to use it on their own. Lilly is also committed to providing affordable access to Emgality for as many patients as possible. Our 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

PainRelief.com: What are the main indications? Will primary care providers be able to prescribe it?  Will it be covered by insurance plans?           

Response: Emgality was approved by the FDA for the preventive treatment of migraine in adults.

Lilly is committed to ensuring patients with migraine have access to Emgality. Patients with commercial insurance are eligible to receive Emgality for up to 12 months free as part of Lilly’s patient support program, though terms and conditions do apply.

Lilly’s choice to provide Emgality for up to 12 months free to all patients with commercial insurance underscores our 25-year commitment to recognizing and working to address the unmet need experienced by those with migraine.

Additionally, in May 2018, Lilly announced that galcanezumab-gnlm met its primary endpoint in a Phase 3 study of patients with episodic cluster headache, demonstrating statistically significant reduction of weekly cluster headache attacks compared to placebo across weeks one to three of the two-month, double-blind treatment period. Based on results from the episodic cluster headache trial, we plan to submit a supplemental BLA to the FDA later this year.

PainRelief.com: Is there anything else you would like to add? 

Response: 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.

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