Eli Lilly’s Emgality cleared for treatment of migraine in Europe
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.”
Eli Lilly has announced that the US Food and Drug Administration (FDA) has approved Jaypirca …
Daiichi Sankyo has announced that Vanflyta (quizartinib) has been approved in the EU for combination …