LILLY’S EMGALITY® ▼(GALCANEZUMAB) RECEIVES A POSITIVE RECOMMENDATION FROM NICE FOR THE PREVENTION OF EPISODIC AND CHRONIC MIGRAINE

LILLY’S EMGALITY® ▼(GALCANEZUMAB) RECEIVES A POSITIVE RECOMMENDATION FROM NICE FOR THE PREVENTION OF

EPISODIC AND CHRONIC MIGRAINE

• Galcanezumab, a once-monthly injection, is now available through the NHS to prevent migraine in adults who have at least four days with migraine headache each month and for whom at least three previous preventive treatments have failed.1

• NICE estimates that around 144,000 people with episodic migraine and 59,000 people with chronic migraine may be eligible for treatment with galcanezumab.1,2

• Galcanezumab is the first calcitonin gene-related peptide (CGRP) migraine treatment to be recommended by NICE as an option for preventing both episodic and chronic migraine in adults.

BASINGSTOKE, 18 November 2020 – Eli Lilly and Company announced today that the National Institute for Health and Care Excellence (NICE) has recommended EMGALITY® (galcanezumab) as an option for the prevention of migraine in adults with episodic and chronic migraine.1

The decision is based on clinical trials comparing galcanezumab with placebo, in which galcanezumab halved the number of monthly migraine headache days for up to 40% of adults with migraine who had previously tried three or more preventative medicines.1

“This is wonderful news for people living with this very painful and debilitating neurological condition. Both chronic and episodic migraine patients across England and Wales will be able to access an effective drug on the NHS that has been specifically designed to prevent migraine. Migraine significantly impacts the lives of those who live with it and access to this important new medication will be life-changing for many.” said Gemma Jolly, Migraine Trust, Head of Information and Support.

The impact of migraine symptoms can have a significant effect on daily activities, with individual attacks lasting between 4-72 hours, often leading to time off work or education, and a struggle to meet commitments in the home, and socially.3,4 Chronic migraine is defined as having a headache on more than fifteen days per month over a three-month period, with at least 8 of those headache days having migraine features, while episodic migraine is defined as less than 15 headache days per month.4.

Dr Mark Weatherall, Chair of the British Association for the Study of Headache, said:

"Migraine is one of the most common neurological disorders in the world, and many patients are highly disabled by their attacks. Despite this fact, there are very few treatments specifically designed to prevent this often debilitating condition. This is why the NICE recommendation of galcanezumab is so exciting: it will give us the opportunity to translate the clinically meaningful benefits seen in clinical trials into the real world, with a treatment that is convenient and well tolerated. We are entering an era when we can provide more targeted treatments for people who suffer from episodic and chronic migraine."

“Migraine is a complex neurological disease which can have a negative impact on all aspects of life, including family, work and social relationships. Lilly welcomes this decision which offers a valuable new treatment option for patients living with this debilitating condition.” said Jyun Yan Yang, Senior Medical Director Eli Lilly and Company, UK, and Northern Europe. “Galcanezumab is one of an innovative class of drugs called CGRP antagonists which have been developed specifically for the prevention of migraine and we are pleased to see the results of many years of scientific effort.”

The NICE decision was based upon clinical-effectiveness results from the CONQUER, REGAIN, EVOLVE-1 and EVOLVE-2 trials which showed that galcanezumab reduced the number of monthly migraine days more than placebo for episodic and chronic migraine.1 These studies have shown that the most common side effects with galcanezumab (which may affect more than 1 in 10 people) are reactions at the site of injection such as pain, redness, itching, bruising or swelling.5