Lilly migraine new drug Emgality has been approved by the European Union as Europe's third CGRP targeted drug

Galcanezumab, the new migraine drug from US pharmaceutical giant Eli Lilly, has been in the news of major EU regulations in recent days. The European Commission (EC) has approved Emgality injections for preventive treatment of migraines in adults, specifically for adult patients who experience migraines for at least four days a month. Emgality will provide a monthly, self-injected subsemptic injection for adult patients with migraines in Europe. In the U.S., Emgality was approved by the FDA at the end of September.
this approval makes Emgality the third migraine drug to target CGRP approved in Europe, following Novar3/Ajin Aimovig and Fremanezumab. In terms of medication, Both Aimovig and Emgality have monthly subsemptic injections, while Ajovy can be injected once a month or every 3 months, making medication more convenient and providing patients with a differentiated treatment option.
is a common chronic neurovascular disease characterized by recurrent severe headaches, mostly on the side. Currently, there is no cure for migraines. The World Health Organization (WHO) has listed migraines as one of the 10 most disabling diseases. Globally, it is estimated that approximately 90 per cent of migraine patients have a seizure migraine (EM), characterized by up to 14 days per month of migraine days, and the remaining 10 per cent are chronic migraines (CM), characterized by at least 15 days of headache per month, of which 8 days and more are migraines, with the patient's condition lasting more than 3 months.
Emgality's approval is based on positive data from 2 Phase III clinical studies (EVOLVE-1, EVOLVE-2) in patients with seizure migraines (EM) and one Phase III clinical study (REGAIN) in patients with chronic migraines (CM). The study, which involved 2,901 patients, showed that Emgality across the migraine spectrum showed clinical and statistically significant results in reducing the number of migraine days per month compared to placebos.
It's worth noting that in the middle of this month, Lilly also submitted to the FDA a new drug application for the oral migraine drug lasmiditan (NDA) for acute treatment of migraines accompanied or not accompanied by pre-eclampsia in adult patients. Lasmiditan is an oral, central nervous system permeability, selective, 5-serotonin 1F (5-HT1F) agonist, structurally and institutionally different from the currently approved migraine drugs, and there is no vasosy activity. Lilly said lasmiditan was the first and only drug molecule evaluated for acute treatment of migraines in adults, and if approved, the drug would represent the first major innovation in migraine treatment in more than 20 years.
, Lilly also announced plans to submit a Supplemental Biologics License (sBLA) to the FDA by the end of the year for preventive treatment for adult seizure plexual headaches. Previously, the FDA had granted Emgality the right to treat breakthrough drugs for seizure-intensive headaches. Currently, there is no drug approved in the United States for preventive treatment of seizure plexual headaches.Emgality: The third migraine drug on the world market to target CGRP
Emgality targets blocking the calcitonin gene-associated peptide (CGRP) subject, which plays a key role in migraine occurrence. CGRP is a neuropeptide that has been shown to be released during migraine seizures and is considered a trigger for migraine seizures. At present, CGRP subject has become a hot target for migraine drug research and development.
In addition to the three antibody drugs approved above, Alder's single-anti-drug eptinezumab (March 1) has completed Phase III clinical development, with a response rate of up to 100% in some patients, and will file a listing application with the FDA in the first quarter of 2019. In addition, a number of companies are developing oral CGRP inhibitors, including Aer Jian's Atogepant and Biohaven's Rimegepant.
March, Corevean released "The 12 Most Interesting Drugs of 2018", predicting aiming for Sales of $1.17 billion in 2022, while Teva Ajovy will be second with $999 million, Lilly's Emgality will be third with $546 million and Eptinezumab will be fourth with $368 million. However, due to strong clinical data, eptinezumab's sales will grow at a high rate and are expected to reach $946 million by 2023. (Bio Valley)