[perspective] great! The first preventive migraine drug approved by FDA, Amgen leads CGRP

On May 17, 2018, the U.S Food and Drug Administration approved the new drug aimovig (erenumab aooe) for the prevention and treatment of adult migraine Aimovig, developed by Amgen, is the first all human monoclonal antibody to prevent migraine by blocking the activity of calcitonin gene-related peptide (a molecule involved in migraine attack) It is the first batch of preventive migraine treatment drugs obtained by FDA, and its treatment cycle is once a month, and the drug can be self injected Eric bastings, M.D., deputy director of Neurology products at the center for drug evaluation and research, U.S Food and drug administration, said: "the birth of aimovig provides patients with a new way to reduce the frequency of migraine, and we need to use such a new method to reduce the headache and debilitating symptoms of patients." Industry insiders predict that aimovig's sales will reach a maximum of $1.2 billion, ranking 12th in 2018 The important value of aimovig is to prevent migraine Migraine is a persistent disease It is the third most prevalent disease in the world and the sixth most disabling disease in the world According to statistics, the incidence rate of migraine in women is three times that of men, and more than 10% of the world's population has suffered from this disease In the United States alone, there are about 38000000 people Its damage to the body is continuous, and patients often suffer from a series of repeated attacks of different factors, including stress, hormone changes, bright or flashing lights, lack of food, sleep and diet Because of its precursory pain onset, about one third of people suffering from pain can predict the onset of migraine, so about 40% of migraine patients can receive preventive treatment In the field of migraine, the competition of small molecule CGRP (calcitonin gene-related peptide) is more intense in recent years CGRP is predicted to be the standard treatment of migraine in the future High CGRP activity is considered to be the main cause of migraine and cluster headache Due to the wide distribution of CGRP and its receptor in vivo, the complete inhibition of this signaling pathway by oral small molecule CGRP receptor antagonists will inevitably lead to serious side effects Two oral CGRP inhibitors (MK-0974 and mk-3207) of mosadong failed in 2011 due to the problem of hepatotoxicity Based on this, pharmaceutical companies change their perspective and focus on local injection of McAbs Teva, Lilly, Amgen and alder are four companies competing fiercely in the field of CGRP Currently, Amgen and Novartis are at the front As early as January 2018, Amgen announced positive results in its phase 3B clinical trial of 140 mg of aimovig (erenumab), a new drug for migraine The study showed that in patients with episodic migraine who had experienced 2-4 times of failure of preventive treatment, there were significantly more patients who used aimovig than those in placebo group, and the number of days of migraine per month decreased by at least 50%, reaching the main end point of the study However, the end of the study was completely closed when the FDA announced approval of the drug on May 17, 2018 Currently, Lilly is also waiting for FDA's review comments It is expected to get results in the third quarter, and the listing will be later than Amgen and Novartis Fremanezumab, a CGRP drug of TIWA, was expected to receive FDA review comments in June, but at the beginning of this month Teva admitted that the approval and marketing of the product would be delayed because the manufacturing process of the drug could not be solved in time In March, alder announced CEO resignation and restructuring, which affected CGRP drug product development, leaving alder far behind the leader The approval was based on three clinical trials of aimovig, which evaluated the positive results of its effectiveness in the treatment of migraine The first study included 955 participants with a history of migraine attacks and compared aimovig with placebo Over a six-month period, the average number of migraine days per month in patients treated with aimovig was one to two months less than in patients treated with placebo The second study included 577 patients with a history of migraine attack and compared aimovig with placebo Over a three-month period, patients treated with aimovig had an average of one migraine headache per month less than those on placebo The third study evaluated 667 patients with chronic migraine and compared aimovig with placebo In this study, patients treated with aimovig were on average two times less per month than those treated with placebo over a three-month period The most common side effects in clinical trials are reactions at the injection site and constipation Finally, it is worth mentioning that the commercial value of aimovig's approval not only consolidated Amgen's leading position in the commercial competition of CGRP migraine drugs, but also increased immeasurable revenue for Amgen and Novartis Amgen has the exclusive right to the drug in Japan, while Novartis has the exclusive right to commercialize the drug in other regions except Japan.