Competition in the field of migraine intensifies! The fourth CGRP targeting antibody-Lingbei Vyepti was approved by the US FDA for intravenous infusion every 3 months!

February 23, 2020 / BIOON / -- lundbeck recently announced that the U.S Food and Drug Administration (FDA) has approved vyepti (eptinezumab jjmr) for the preventive treatment of adult migraine It is worth mentioning that vyepti is the first FDA approved intravenous (IV) therapy for migraine prevention The recommended dose of vyepti is 100mg once a quarter (3 months), and some patients may benefit from 300mg Lingbei plans to bring vyepti to market in April 2020 The drug was developed by alder biopharmaceuticals, a biopharmaceutical company based in Bossel, Washington, focusing on migraine In September 2019, Lingbei acquired alder with a total cash value of US $1.95 billion The acquisition aims to speed up and strengthen the pipeline construction in Lingbei Lingbei previously said that the migraine drug vyepti acquired by the acquisition is an exciting product, which will expand its portfolio to migraine, an important step in the company's expansion and investment growth strategy Dr Deborah dunserie, President and CEO of Lingbei, said: "with the approval of vyepti, I am glad that we are now able to provide a new intravenous therapy to achieve the key treatment goal of preventing migraine over time, while also meeting the need for early effectiveness The vyepti clinical program was the first to demonstrate this early benefit, in clinical studies, two doses of vyepti showed therapeutic benefits on the first day after infusion compared to placebo " The efficacy and safety of vyepti were confirmed in two phase III clinical trials, promise 1 (nct02559895) and promise 2 (nct02974153) The two trials evaluated the efficacy and safety of vyepti in the prophylactic treatment of paroxysmal migraine (n = 888) and chronic migraine (n = 1072) The results showed that all primary and secondary endpoints were achieved in both studies Compared with placebo, two doses (100mg, 300mg) of vyepti showed therapeutic benefits on the first day after intravenous infusion, and the proportion of patients who experienced a migraine attack for most of the first seven days was lower than that of placebo group The safety of vyepti was evaluated in 2076 migraine patients who received at least one dose of vyepti In the clinical trials of prophylactic treatment of migraine, the most common adverse reactions (incidence ≥ 2%, and at least 2% higher than placebo) were nasopharyngitis hypersensitivity In the promise-1 and promise-2 trials, 1.9% of patients who received vyepti stopped treatment due to adverse reactions Dr Peter goadsby, Professor of Neurology at the University of California, said: "the data from the promise-2 trial show that many patients can reduce migraine days by at least 75%, and the continuous improvement of migraine during the six-month treatment period is of clinical significance to doctors and patients Vyepti is a valuable supplement to migraine treatment and can help reduce the burden of this serious disease " Migraine is the third most common disease and the sixth general disability disease in the world It is a common chronic neurovascular disease, characterized by recurrent severe headache, mostly laterally It is estimated that the total number of migraine patients in the world is more than 1 billion, about 90% of them are episodic migraine (EM), which is characterized by 14 days of migraine per month; the remaining 10% are chronic migraine (CM), which is characterized by at least 15 days of headache per month, of which 8 days and more are migraine, and the patient's condition lasts for more than 3 months At present, there is no medicine to cure migraine The World Health Organization (who) has listed migraine as one of the top 10 most disabling diseases Compared with other people, migraine patients are more likely to have depression, anxiety, sleep disorders, other pain and fatigue The active drug component of vyepti is eptinezumab, which is a humanized IgG1 monoclonal antibody targeting to calcitonin related gene peptide (CGRP) ligand and blocking its binding to receptor CGRP, a neuropeptide, has been shown to be released during migraine attacks, which may be the cause of migraine attacks At present, CGRP and its receptor have become the hot target of migraine drug development Up to now, there are four McAb migraine therapies targeting CGRP and its receptor on the market In addition to vyepti, the other three therapies are: Amgen / Novartis aimovig (targeting CGRP receptor), Tyva ajovy (targeting CGRP) and Lilly emgality (targeting CGRP) In terms of medication, vyepti is injected intravenously every three months, aimovig and emgality are injected subcutaneously every month, ajovy can be injected subcutaneously once a month or every three months Other pharmaceutical companies are developing oral CGRP receptor antagonists In December 2019, ubrogepant was approved by FDA for acute treatment of adult migraine (with or without aura), becoming the first oral CGRP receptor antagonist approved for migraine attack in the world At present, biohaven company also has an oral CGRP receptor antagonist zydis ODT (rimegepant orally disintegrating tablets) which is under the review of FDA in the United States, and is expected to be approved in the first quarter of 2020; in addition, rimegepant conventional tablets are also under the review of FDA, and is expected to be approved in the middle of 2020 In terms of acute treatment of migraine, it is particularly worth mentioning that in October 2019, the oral drug leyvow (lashiditan) was approved by the US FDA for acute treatment of adult migraine (with or without aura symptoms) This approval is of great significance It is a 5-HT1F agonist and the first new type of acute migraine treatment drug approved in 20 years However, going public first doesn't necessarily bring you the last laugh The data of phase III study of acute migraine show that rimegepant is better than ubralvy and reyvow is better than rimegepant, but reyvow has side effects and is controlled by DEA Evaluatepharma, a pharmaceutical market research firm, forecasts that rimegepant's sales will reach $897 million in 2024, while reyvow's and ubralvy's sales in the same period are expected to reach $317 million and $302 million, respectively (BIOON Com) original source: FDA app roads lundbeck's vyepti Gamma (eptinezumab-jjmr) – The First and Only Intravenous Preventive Treatment for Migraine