20 years of major innovation! Lilai 5-HT1F agonist reyvow has been approved by the US FDA, the first new type of acute migraine treatment drug!

October 12, 2019 / BIOON / -- pharmaceutical giant Eli Lilly recently announced that the U.S Food and Drug Administration (FDA) has approved reyvow (lasmiditan), an oral drug, for acute treatment of migraine in adults with or without premonitory symptoms The approval is significant because reyvow represents the first new class of acute migraine drugs approved by FDA in more than 20 years It should be noted that reyvow is not suitable for the prophylactic treatment of migraine The dosage specifications of the drug are 50mg, 100mg and 200mg, which can be selected according to the needs Migraine is a common chronic neurovascular disease, characterized by recurrent severe headache, mostly laterally 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 The active component of reyvow is lasmiditan, which is an oral, central nervous system permeable, selective, 5-hydroxytryptamine 1F (5-HT1F) agonist It is different from the currently approved migraine drug in structure and mechanism, and has no vasoconstrictive activity It is worth mentioning that lasmiditan is the first and only drug molecule approved for acute treatment of migraine in adults This approval represents the first major innovation in the treatment of acute migraine in more than 20 years Like other drugs with central nervous system (CNS) activity, the FDA requires a study of the abuse potential of reyvow Abuse potential refers to the possibility of abuse of specific drug products or substances with CNS activity In line with FDA guidelines, Lilly conducted an assessment of human abuse potential; as part of the assessment, the therapeutic dose of reyvow was associated with fewer drug preferences than alprazolam, but more than placebo Currently, the US Drug Enforcement Agency (DEA) is reviewing the classification of controlled substances recommended by reyvow, which is expected to be completed within 90 days of FDA approval today, after which reyvow can be sold in retail pharmacies Patrik Jonsson, senior vice president and President of Lilly biomedical, said: "for 25 years, Lilly has been working to help patients with disabling headache disease, investigating more than 10 different compounds Reyvow's approval is an exciting development for patients and doctors looking for pain relief potential in migraine attacks " Reyvow's approval is based on data from two phase III studies (samurai, Spartan) These studies evaluated the efficacy and safety of reyvow in the treatment of migraine, and reached the primary and secondary endpoints of the study In both studies, a significantly higher proportion of patients in the reyvow treatment group experienced a complete elimination of migraine pain at 2 hours after the first administration, and a significantly higher proportion reported a complete elimination of their most annoying symptoms (MBS, selected by patients from nausea, light sensitivity or voice sensitivity), compared with the placebo group In the study, the treatment-induced adverse events were generally mild to moderate, and the most common adverse events included dizziness, fatigue, sensory abnormalities (tingling or numbness of the skin), sedation, nausea and / or vomiting, and muscle weakness Reyvow's phase III development involved more than 4000 patients and more than 20000 migraine episodes The project also includes open label Gladiator research In terms of headache treatment, Lilly has a product on the market The company's antibody drug emgality (galcanezumab gnlm) 120mg injection was approved by the US FDA in September 2018 for adult migraine prevention In June, emgality was approved by the FDA to reduce the frequency of adult onset cluster headache (ECH) It is worth mentioning that this approval makes emgality the first and only drug to treat ECH It is also the first and only anti CGRP antibody approved by FDA to treat two different headache diseases Emgality targeted to block calcitonin gene-related peptide (CGRP) receptor, which plays a key role in migraine CGRP, a neuropeptide, has been shown to be released during migraine attacks and is believed to be an inducement to migraine attacks At present, CGRP receptor has become a hot target of migraine drug development In addition to emgality, approved antibody drugs include Novartis / Amgen aimovig (erenumab aooe) and ajovy (fremanezumab vfrm) In terms of medication, emgality and aimovig are injected subcutaneously once a month, ajovy can be injected subcutaneously once a month or once every three months, which is more convenient in terms of medication and will provide patients with a differentiated treatment option In addition, the monoclonal antibody eptinezumab of alder biopharmaceuticals was reviewed in the United States in April this year The drug is infused intravenously every three months, with a high response rate of 100% in some patients It is worth mentioning that last month, Lingbei pharmaceutical purchased alder company for us $1.95 billion In addition to the antibody drugs mentioned above, some companies are developing oral CGRP inhibitors, including atogepant of Erjian and rimegepant of biohaven Lilly's reyvow Gamma (lasmiditan), The First and Only Medicine in a New Class of Acute Treatment for Migraine, Receives FDA Approval