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    Home > Medical News > Medical Science News > First oral CGRP-subject antagonist migraine drug! El Jian ubrogepant will submit a listing application in early 2019:

    First oral CGRP-subject antagonist migraine drug! El Jian ubrogepant will submit a listing application in early 2019:

    • Last Update: 2021-02-14
    • Source: Internet
    • Author: User
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    Allergan recently announced that it has completed two clinical studies of ubrogepant for acute migraine treatment and has obtained positive safety and tolerance data.
    first study (UBR-MD-04) assessed the long-term safety and tolerance of ubrogepant (50mg and 100mg) for acute treatment in adult patients with migraines compared to one year of routine care, and the data continued to support ubrogepant's positive safety and tolerance characteristics. The second study (3110-105-002) assessed the liver safety and tolerance of ubrogepant (100mg) relative to placebo therapy for 8 weeks in health study participants, and confirmed that ubrogepant did not have a drug-induced liver injury signal in healthy volunteers.
    based on the successful completion of the above-mentioned ubrogepant 2 safety studies, as well as the previously reported 2 key Phase III clinical studies from ubrogepant for migraine treatment (ACHIEVE I (UBR-MD-01), ACHIEVE II (UBR-MD-02)) Efficacy and Safety Data, AerGen has planned to file a new drug application (NDA) with the FDA in the first quarter of 2019, and the company expects the ubrogepant NDA to be the first oral CGRP-subject antagonist submitted in the U.S. market for acute treatment of migraines (with or without precursors).
    ubrogepant is a new, efficient, oral calcitonin gene-related peptide (CGRP) peptide antagonist currently being developed for the treatment of acute migraines. CGRP and its subjects are expressed in areas of the nervous system associated with migraine pathophysiology. CGRP-subject antagonist is a new mechanism of action for acute migraine therapy, which is significantly different from that of existing quentins (serotonin 1B / 1D astrists) and opioids. At present, CGRP subject has become a hot target for migraine drug research and development.
    so far, three single-resistant migraine drugs targeting CGRP receptors have been introduced: Novarian/Amgen Aimovig (erenumab-aooe), Teva Ajovy (fremanezumab-vfrm), and Lilly Emgality (galcanezumab-gnlm). 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.
    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, in addition to ubrogepant, Aer Jian has another drug 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)
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