lilly_entrance_web

Eli Lilly’s Emgality cleared for treatment of migraine in Europe

pharmafile | November 20, 2018 | News story | Manufacturing and Production, Sales and Marketing EU, Eli Lilly, Emgality, Europe, migraine, pharma 

Eli Lilly’s Emgality (galcanezumab) has secured approval from the European Commission for the prophylaxis of migraine in adult patients who have at least four days affected by the condition per month, it has emerged.

The self-administered, once monthly subcutaneous injection was shown to provide superior reduction in monthly migraine headache days (MHD) and an improvement in functioning in three Phase 3 studies of participants with episodic and chronic migraine.

Data generated from these trials showed that Emgality hit all primary endpoints of a statistically significant mean reduction from baseline of monthly MHDs compared to placebo in the first month of treatment and every following month. In the two trials of patients with episodic migraine, 60% of patients achieved at least a 50% reduction on average in MHDs in any given month compared to 38.6% and 36% with placebo, while more than a third of patients achieved a 75% or greater reduction on average.

The approval comes on the heels of a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), issued in September earlier this year.

“Severe migraine is a debilitating disease with limited treatment options,” commented Dr Arash Tahbaz, Senior Medical Director UK and Northern Europe. “This approval marks another major milestone for galcanezumab, and offers the potential for reducing the number and severity of migraine attacks for patients and improving their quality of life.”

Matt Fellows

Related Content

1200px-vaccine_image_1

GSK’s RSV vaccine approved in EU for older adults

GSK has announced that the European Commission (EC) has authorised Arexvy, the company’s respiratory syncytial …

NICE recommends Pfizer’s rimegepant for preventing episodic migraine attacks

The National Institute for Health and Care Excellence (NICE) has announced that it has recommended …

towfiqu-barbhuiya-hn2hqoalbck-unsplash_1

European Parliament shares goal to tackle antimicrobial resistance

The European Parliament has shared its recommendations for a “coordinated EU response to health threats …

Latest content