Lilly Emgality has been approved by the FDA as the third CGRP targeted drug to hit the market

Eli Lilly, the US pharmaceutical giant's new migraine drug, Galcanezumab-gnlm, has had some big regulatory news in recent days. The U.S. Food and Drug Administration (FDA) has approved the Emgality 120mg injection for preventive treatment of migraines in adults. Emgality will provide a monthly, self-injected subsoil injection drug for adult migraine patients, which is strictly prohibited for patients with severe allergies to galcanezumab-gnlm or any exfusion.
this approval makes Emgality the third migraine drug to target CGRP, following Novarian/Aonumab-aooe and Fremanezumab-vfrm. 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.
pricing, the wholesale purchase costs of each of the three drugs are $575 per month and $6,900 per year. As part of Lilly's Patient Support Program, patients with commercial insurance receive up to 12 months of Emgality treatment free of charge. Teva also has a similar patient support program, with commercially insured patients getting Ajovy treatment free of charge until the offer expires.
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. Migraines affect more than 30 million adults in the United States, and the total unrejusted cost associated with migraines is estimated at $56 billion a year.
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 data showed that Emgality across the migraine spectrum showed clinical and statistically significant results in reducing the number of migraine days per month compared to placebo.
, 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) is also in Phase III clinical development, with a response rate of up to 100% in some patients and is expected to be submitted for market in 2018. 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)