dm+d

Unassigned

New Medicines

VyeptiMigraine prophylaxis

Information

Vyepti
New molecular entity
Lundbeck
Lundbeck

Development and Regulatory status

Phase III Clinical Trials
Pre-registration (Filed)
Launched
Nov 20Currently pre-registration in EU. Has been filed using the centralised procedure [16].
May 20Lundbeck plans to submit eptinezumab for approval to European Union regulatory authorities by the end of 2020 [14].
Apr 20Launched in the US [13].
Feb 20Approved in the US [8].
Nov 19Lundbeck is to market eptinezumab in the UK [7].
Oct 19Lundbeck has acquired Alder Bio for a price that could be up to $1.9 billion, and re-badged it as Lundbeck Seattle [9].
Feb 19Alder has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) [5].
May 18Analysts predict launch in US in 2020, and in territories outside the US in 2021 [4].
Jun 17Alder plans to file a biologics license application (BLA) submission to the FDA in the second half of 2018 [1].

Category

Human monoclonal antibody that works by inhibiting the calcitonin gene-related peptide receptor believed to transmit signals that can cause incapacitating pain.
Numbers may be misleading, as many who experience migraine do not consult their GP, but migraine affects about 6% of men and 18% of women. In children it is more common in boys than in girls. The first attack is often in childhood and over 80% have had their first attack by the age of 30 [2].
Migraine prophylaxis
Intravenous infusion

Further information

Yes
To be confirmed

Trial or other data

Jun 21PIII RELIEF study is published in JAMA [18].
Apr 21Abstracts published with data from the PIII 4-12 week RELIEF study. With 100mg eptinezumab, pts achieved time to freedom from headache pain ([HR]=1.54, p=0.0006) and time to absence of their most bothersome symptom (MBS) (HR=1.75, p<0.0001) earlier than placebo. Median time to headache pain freedom was 4 with vs. 9 hours. Median time to absence of the MBS was 2 vs. 3 hours with placebo. Headache pain freedom was reported by 23.5% with eptinezumab vs. 12% with placebo (p=0.0009), while absence of MBS was reported by 55.5% with eptinezumab vs. 35.5% on placebo (p<0.0001). A second abstract looking at exploratory endpoints suggested that, when initiated during a migraine, eptinezumab delayed the time to next migraine by a median of 10 days vs. 5 days with placebo. [17]
Mar 20The PROMISE 2 study (n=1072) is published in Neurology [12].
Mar 20The PROMISE 2 study met its primary endpoint, demonstrating statistically significant reductions in mean monthly migraine days (MMD) after the first dose of eptinezumab over months 1-3. Both evaluated doses (100 mg and 300 mg) reduced mean MMD vs. placebo over months 1-3 (p<0.0001). MMD decreased by 7.7 days for 100 mg, 8.2 days for 300 mg, and 5.6 days for placebo. Estimated mean changes in the average daily percentage of pts with a migraine from baseline over month 1: -27.1% for 100 mg, -29.8% for 300 mg and -18.8% for placebo. Treatment was well tolerated with similar rates of treatment-emergent adverse events (TEAE) vs. placebo. [11]
Jul 19Post-hoc analyses of PROMISE-1 and PROMISE-2 demonstrate efficacy of eptinezumab for migraine prevention. Results showed 63.3% of episodic migraine patients & 34.6 % of chronic migraine patients treated with 100 mg eptinezumab achieved at least one migraine-free month, over a 1-year and 6 month study, respectively vs. 12.6% and 22.4% of placebo patients [6].
Jan 18Eptinezumab met the primary endpoint in pivotal PIII PROMISE 2 trial. Top line results show that following a single quarterly eptinezumab administration, the primary endpoint was met: reduction of 8.2 monthly migraine days from baseline vs. 5.6 days for placebo, p<0.0001. Eptinezumab met all key secondary endpoints including prevention beginning Day One (p<0.0001) and 50% (p<0.0001) and 75% (p<0.0001) responder rates months 1-3. Furthermore, 15% of eptinezumab patients had no migraines (i.e., 100 percent response) for a full 3 months (p<0.0001 unadjusted). Safety and tolerability were similar to previously reported eptinezumab studies.[3]
Jun 17Recruitment to PIII NCT02974153 is ongoing. PROMISE 2 (PRevention Of Migraine via Intravenous ALD403 Safety and Efficacy 2) is evaluating the safety and efficacy of two dose levels of eptinezumab versus placebo, administered by infusion once every 12 weeks in patients living with chronic migraine. [3].
Jun 17Results from PIII PROMISE 1 trial show a superior reduction in monthly migraine days for eptinezumab vs placebo (4.3 vs 3.2 days, p=0.0001). The % of patients with ≥75% reduction in monthly migraine days was 31.5% for eptinezumab 300 mg vs 20.3% for placebo (p=0.0066) [1].

Evidence based evaluations

VyeptiEpisodic cluster headache

Information

Vyepti
Licence extension / variation
Lundbeck
Lundbeck

Development and Regulatory status

None
None
Phase III Clinical Trials

Category

Human monoclonal antibody that works by inhibiting the calcitonin gene-related peptide receptor believed to transmit signals that can cause incapacitating pain.
About 1 in 1,000 people suffer from cluster headache. It is a disease of long, sometimes lifelong duration. More men than women are affected, particularly in chronic CH. The overall sex ratio was 4.3 (male-to-female) [1].
Episodic cluster headache
Intravenous infusion