Lundbeck CGRP targeting antibody Vyepti reviewing by EU
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Lundbeck CGRP targeting antibody Vyepti reviewing by EU.
Leedbeck CGRP targeting antibody Vyepti enters the review in the European Union: it takes effect on the first day and is administered intravenously 4 times a year!
Lundbeck recently announced that the European Medicines Agency (EMA) has accepted a marketing authorization application (MAA) for the migraine drug Vyepti (eptinezumab).
The application seeks approval for Vyepti for migraine patients who are eligible for preventive therapy.
Vyepti is the newest strategic brand in the Lundbeck product portfolio. As a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP), Vyepti can prevent CGRP from binding to its receptor, thereby preventing migraine attacks.
Vyepti is the first migraine preventive antibody drug given by intravenous injection (IV). It can provide some benefits, such as the drug reaches a therapeutic level in the blood immediately and is effective on the day of infusion.
Vyepti is administered once every 3 months (12 weeks) and intravenous infusion for 30 minutes each time.
The drug can provide preventive treatment for migraine patients, requiring only 4 treatments per year.
EMA accepts Vyepti MAA sign EMA Committee for Medicinal Products for Human Use (CHMP) has begun a formal review of this new therapy. Vyepti was approved by the US FDA on February 22, 2020 for the preventive treatment of adult migraine, and it was launched in the US market in April.
During 2020, Lundbeck submitted Vyepti marketing authorization applications in multiple countries, including Canada, Australia, Switzerland, the United Arab Emirates, Kuwait, the Philippines, Singapore, Indonesia and Brazil.
Development activities in other regions and countries of the world including China and Japan are being planned.
Dr. Johan Luthman, Executive Vice President of R&D of Lundbeck, said: “Lundbeck is pleased to accept Vyepti’s regulatory review by EMA.
The drug will address the need for migraine preventive drugs with early onset and strong efficacy. Many patients are affected by migraine.
They deserve innovative and better treatments, including effective, rapid and long-lasting migraine prevention.
Therefore, we look forward to working closely with European regulatory authorities to provide Vyepti to European migraine patients as soon as possible.”
Migraine is a common chronic neurovascular disease characterized by recurrent severe headaches, mostly hemilateral.
Currently, there are no drugs that can cure migraines. The World Health Organization (WHO) has listed migraine as one of the 10 most disabling diseases.
Vyepti was developed by Alder BioPharmaceuticals, and Lundbeck acquired Alder for USD 1.95 billion in September 2019. In the United States, Vyepti was approved in February this year for the preventive treatment of adult migraine.
Vyepti is administered by intravenous infusion, and the recommended dose is 100 mg once a quarter (3 months). Some patients may benefit from the 300 mg dose.
It is worth mentioning that Vyepti is the first and only intravenous (IV) therapy for migraine prevention.
It will provide patients with an effective and universally tolerated treatment, requiring only 4 intravenous infusions per year.
The active pharmaceutical ingredient of Vyepti is eptinezumab, which is a humanized IgG1 monoclonal antibody that targets calcitonin-related gene peptide (CGRP) ligands and blocks its binding to the receptor.
CGRP is a neuropeptide that has been shown to be released during migraine attacks and may be the cause of migraine attacks.
Currently, CGRP and its receptors have become popular targets for migraine drug development.
Up to now, there have been 4 monoclonal antibody migraine therapies that target CGRP and its receptors.
In addition to Vyepti, the other three are: Amgen/Novartis Aimovig (targeting CGRP receptor), Ajovy (targeting CGRP), Eli Lilly Emgality (targeting CGRP). In terms of medication, Vyepti is given by intravenous infusion every 3 months, Aimovig and Emgality are given by subcutaneous injection once a month, and Ajovy can be given by subcutaneous injection once a month or every 3 months.
Other pharmaceutical companies are developing oral CGRP receptor antagonists.
Currently on the market are Allergan’s Ubrelvy (ubrogepant) and Biohaven’s Zydis ODT (rimegepant orally disintegrating tablets), two drugs for the acute treatment of adult migraine (with or without aura).
It is particularly worth mentioning that in October 2019, Eli Lilly’s oral drug Reyvow (lasmiditan) was approved by the US FDA for the acute treatment of adult migraine (with or without aura symptoms). The drug is a 5-HT1F agonist and is the first new class of acute migraine treatment approved in 20 years.
Lundbeck CGRP targeting antibody Vyepti reviewing by EU.
(source:internet, reference only)
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