Lundbeck’s Vyepti secures US approval for migraine prevention
Lundbeck’s Vyepti (eptinezumab-jjmr) has secured approval from the FDA, it has emerged, for the prevention of migraine in adult patients.
The drug was tested in two Phase 3 trials, the first evaluating its efficacy in episodic migraine, and a second in chronic migraine.
In the first trial, comprised of 665 patients, monthly migraine days (MMD) were reduced on average from baseline by 3.9 days with 100mg dosing and 4.3 days with 300mg dosing of Vyepti, compared to 3.2 days with placebo. In these same groups, 49.8% and 56.3% saw a reduction in MMD by at least 50%, compared to 37.4% of placebo patients.
Furthermore, a reduction of at least 75% was achieved by 22.2% and 29.7% of those receiving 100mg and 300mg Vyepti, compared to 16.2% with placebo.
In the second study of 1,072 patients, Vyepti produced an average reduction of 7.7 days and 8.2 days from baseline in the 100mg and 300mg groups, compared to 5.6 days with placebo. Additionally, 57.6 and 61.4% of patients in the 100mg and 300mg groups achieved an MDD reduction of at least 50%, while this was achieved by just 39.3% of placebo patients. These scores stood at 26.7% and 33.1% respectively for those who achieved a reduction of at least 75%, compared to 15% with placebo.
“The PROMISE-2 data showed that many patients can achieve reduction in migraine days of at least 75% and experience a sustained migraine improvement through six months, which is clinically meaningful to both physicians and patients,” commented Dr Peter Goadsby, a Professor of Neurology at King’s College, London and the University of California, San Francisco. “Vyepti is a valuable addition for the treatment of migraine, which can help reduce the burden of this serious disease.”
Lundbeck confirmed that Vyepti will be available in April this year.
Dr Deborah Dunsire, President and CEO of Lundbeck, also remarked: “With the approval of Vyepti, I am pleased that we are now able to offer a new IV therapy that achieves the key treatment goal of preventing migraine over time while also delivering on the need for earlier onset of efficacy. The Vyepti clinical programme is the first to demonstrate this early benefit.”
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