New migraine medicine! Lingbei CGRP targeted antibody Vyepti during migraine attack preventive treatment PHASE III study was successful!

September 05, 2020 // -- Lundbeck recently released top-line data for the migraine drug Vyepti (eptinezumab) III RELIEF Study (NCT04152083).
confirmed that Vyepti, as a preventive treatment, has significant effects during migraine attacks, allowing headaches and the most annoying symptoms to disappear more quickly.
RELIEF was a parallel, randomized, double-blind, placebo-controlled study conducted in migraine patients suitable for preventive treatment to assess the efficacy and tolerance of Vyepti in initiating treatment during migraine attacks.
the study group experienced migraines 4-15 days a month.
study, the patients were randomly divided into 2 groups and received a single dose of Vyepti or placebo at a 1:1 ratio (n-480) within 1-6 hours of migraine attacks.
study lasted 4-12 weeks, including a screening period of up to eight weeks.
clinical visits occurred during screening, day 0 (day of infusion, first 4 hours after infusion) and 4 weeks.
patients are allowed to use emergency medicines at any time within 2 hours of infusion.
results showed that the study was statistically significant at the common main endpoint: patients who received 100 mg of Vyepti infusions lost their headaches and the most annoying symptoms (a choice between light, fear and nausea) earlier during migraine episodes than those who received a placebo.
addition, the study was statistically significant in terms of key secondary endpoints, including the proportion of patients who lost their headaches and the proportion of patients who lost their most annoying symptoms within 2 hours of starting infusions.
all other secondary endpoints are also statistically significant.
study, Vyepti was well-to-do as a preventive therapy during migraine attacks, consistent with previous Phase III studies, and found no new safety signals.
in clinical trials of migraine prevention therapy, the most common adverse reactions (at least 2 percent more than placebo) were nasopharyngitis and allergic reactions.
of the RELIEF study will be presented at an upcoming scientific conference and will be published in a peer-reviewed journal.
, executive vice president of research and development at Thering North, said: "We are pleased to see that another trial reinforces the early benefits of Vyepti.
We continue to hear from migraine sufferers that the early benefits of preventive treatment are important, which is why Lingbei continues to focus its research on addressing early efficacy and other key treatment goals that are most important to patients.
"Vyepti was developed by Alder Bio Pharmaceuticals, which Lingbei acquired for $1.95 billion in September 2019.
U.S., Vyepti was approved in February for preventive treatment of migraines in adults.
Vyepti is administered intravenously at a recommended dose of 100 mg once a quarter (3 months), and some patients may benefit from a dose of 300 mg.
It's worth noting that Vyepti is the first and only intravenous (IV) treatment to prevent migraines and will provide patients with an effective and universally available treatment that requires only four intravenous infusions per year.
Vyepti's active pharmaceutical ingredient is eptinezumab, a humanized IgG1 monoclonal antibody that targets binding calcitonin-related gene peptide (CGRP) ligands, blocking its binding to receptors.
CGRP is a neuropeptide that has been shown to be released during migraine attacks and may be a trigger for migraine seizures.
, CGRP and its subjects have become a hot target for migraine drug development.
so far, four single-resistant migraine therapies targeting CGRP and its subjects have been launched, in addition to Vyepti, the other three are: Amgen/Novartic Aimovig (targeting CGRP subjects), Teva Ajovy (targeting CGRP), Lilly Emgality (targeting CGRP).
medication, Vyepti is given intravenously every 3 months, Aimovig and Emgality are given once a month, and Ajovy can be injected once a month or every 3 months.
other pharmaceutical companies are developing oral CGRP-subject antagonists.
currently on the market are AerGen's Ubrogepant and Biohaven's Zydis ODT (Rimegepant oral disintegration tablets), two drugs for acute treatment of migraines in adults with or without precursor.
particular note that in October 2019, Lilly's oral drug Reyvow (lasmiditan) was approved by the U.S. FDA for acute treatment of migraines (accompanied by or without precursor symptoms) in adults.
is a 5-HT1F agonist and is the first new class of acute migraine therapy approved in 20 years.
() original source: Positive headline results from the Vyepti (eptinezumab-jjmr) STUDY.