The first oral CGRP migraine drug in the world! Ubrogepant has been approved by FDA for acute treatment of migraine!

December 24, 2019 / BIOON / -- Allergan recently announced that the U.S Food and Drug Administration (FDA) has approved ubrogepant for acute treatment of adult migraine (with or without aura) It is worth mentioning that ubralvy is the first and only oral calcitonin gene-related peptide (CGRP) receptor antagonist approved by FDA for the treatment of migraine attack Migraine is a nervous system disease characterized by intermittent migraine Its symptoms are often disabling Migraine is the third most common disease and the second most disabling cause in the world Elgin has plans to bring ubralvy to the U.S market in early 2020 In clinical studies, a single oral administration of ubrlvy, compared with placebo, quickly eliminated migraine pain and the most annoying symptoms in patients 2 hours after administration In support of FDA approved clinical trials, ubralvy provided rapid pain relief for most patients, and also reached the common primary end point of pain elimination and elimination of the most annoying symptoms (nausea, light sensitivity, sound sensitivity), which is the latest and stricter efficacy standard specified by FDA in 2018 Ubralvy also provides long-lasting relief for up to 24 hours By blocking the binding of CGRP and its receptor, ubrlvy functions in a new way and does not constrict blood vessels, which is the problem of many existing migraine drugs Ubralvy is a non narcotic, non controlled product and has no addiction potential The drug is approved in two doses, 50mg and 100mg, so that the health care provider can provide individualized treatment for patients David Nicholson, executive vice president and chief R & D officer of Elgin, said: "we are very pleased that ubralvy has now been approved by the FDA As the first oral CGRP receptor antagonist, ubrevy will provide a new and different type of acute treatment option for patients suffering from migraine weakness pain and other symptoms The drug has two oral dosage intensity regimens that allow for therapeutic flexibility in migraine attacks As we continue to drive innovation in migraine treatment, we are very proud to offer patients another option, which we believe will benefit patients in need " This approval is based on the successful completion of 4 clinical studies - 2 critical phase III studies (achieve I, achieve 2) And two additional safety studies (ubr-md-043110-105-002) that demonstrated the efficacy, safety, and tolerance of ubrogepant for acute migraine treatment in a wide range of patient groups, including patients with inadequate response to traptan, patients with contraindications to traptan, and patients with moderate to severe cardiovascular risk characteristics ——2 key phase III studies: data confirmed oral ubrogepant (ACHIEVE I study: 50mg and 100mg; ACHIEVE 2: 25 mg and 50 mg) compared with placebo in the treatment of single migraine attack in adults, the efficacy, safety and tolerance were as follows: (1) 50 mg and 100 mg reached the common end point of the study Compared with placebo group, the proportion of patients in ubrogepant group who achieved no pain or most annoying symptoms 2 hours after the first dose increased significantly, and the difference with placebo group has always been significant Continue until the 48th hour (2) The 50 mg and 100 mg doses also reached the critical secondary end point, with a statistically significant increase in the proportion of patients who achieved pain relief 2 hours after the initial dose in the ubrogepant group compared to the placebo group ——Two additional safety studies: ubr-md-04 is a multicenter, randomized, 52 week open label extended phase III study that evaluated the long-term safety and tolerability of ubrogepant (50mg and 100mg) for acute treatment of migraine in adult patients compared with conventional care for one year, with data supporting intermittent use of 50mg or 100mg Ubrogepant has good safety and tolerance in the treatment of acute migraine attack during one year The most common three adverse events are nasopharyngitis, upper respiratory tract infection and sinusitis 3110-105-002 is a multicenter, double-blind, parallel group I study that evaluated the safety and tolerability of ubrogepant (100mg), focusing on high-frequency intermittent administration (2-day ubrogepant) 100 mg, placebo for 2 days, for 8 weeks) in healthy subjects, the data confirmed that after frequent administration, ubrogepant (100 mg) was well tolerated compared with placebo, and had nothing to do with the continuous rise of alanine aminotransferase / glutamic oxaloaminase, supporting the safety of the liver The molecular structure formula of ubrogepant (photo source: Wikipedia) ubrogepant is a new, efficient and oral calcitonin gene-related peptide (CGRP) receptor antagonist, which is an active drug ingredient of ubrogepant, developed for the acute treatment of migraine CGRP and its receptor are expressed in the nervous system related to the pathophysiology of migraine CGRP receptor antagonism is a new mechanism of acute migraine treatment, which is different from the existing triptans (serotonin 1B / 1D agonists) and opioids At present, CGRP receptor has become a hot target of migraine drug development So far, three McAbs targeting CGRP receptor have been listed, respectively: Novartis / ammovig (erenumab aooe), ajovy (fremanezumab vfrm) and emgality (galcanezumab gnlm) In terms of medication, aimovig and emgality 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 company's monoclonal antibody eptinezumab (intravenous infusion once in March) also filed an application for listing in the United States in late February this year In September, Lingbei acquired alder for us $1.95 billion Other companies are developing oral CGRP receptor antagonists In addition to ubrlvy, Elgin also has an oral CGRP receptor antagonist, atogepant, which is developed to prevent migraine Biohaven also has an oral CGRP receptor antagonist, zydis (rimegepant orally disintegrating tablet), which is under FDA review and is expected to be approved in early 2020 In terms of acute treatment of migraine, in mid October this year, leyvow (lashiditan) was approved by the US FDA for acute treatment of adult migraine (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 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 Original source: Allergan receives U.S FDA approve for ubrevy Gamma FOR THE ACUTE TREATMENT OF MIGRAINE WITH OR WITHOUT AURA IN ADULTS