January 29, 2020 / BIOON / -- Teva, an Israeli pharmaceutical giant, recently announced that the US Food and Drug Administration (FDA) has approved the automatic syringe of ajovy (fremanezumab), a migraine drug
The company has plans to bring the product to market in the coming months
Brendan O'Grady, executive vice president of Tyva North America business, said: "the approval of ajovy syringes is another important step forward for Tyva and the migraine community
Ajovy is the only FDA approved anti CGRP migraine therapy that offers a quarterly (675 mg) or monthly (225 mg) dose selection flexibility, and we are pleased that this approved automatic syringe will enable the migraine patient population and their healthcare providers to decide whether the automatic syringe is the right treatment option to meet their needs
" Migraine is the third most common disease and the sixth general disability disease in the world
It is a common chronic neurovascular disease, characterized by recurrent severe headache, mostly laterally
It is estimated that the total number of migraine patients in the world is more than 1 billion, about 90% of them are episodic migraine (EM), which is characterized by 14 days of migraine per month; the remaining 10% are chronic migraine (CM), which is characterized by at least 15 days of headache per month, of which 8 days and more are migraine, and the patient's condition lasts for more than 3 months
At present, there is no medicine to cure migraine
The World Health Organization (who) has listed migraine as one of the top 10 most disabling diseases
Compared with other people, migraine patients are more likely to have depression, anxiety, sleep disorders, other pain and fatigue
Ajovy is a kind of monoclonal antibody drug, which can target and block the binding of CGRP and its receptor
CGRP, a neuropeptide, has been shown to be released during migraine attacks and is believed to be an inducement to migraine attacks
At present, CGRP and its receptor have become the hot target of migraine drug development
Up to now, three McAb migraine prophylactic drugs targeting CGRP or its receptor have been listed, respectively: Novartis / Amgen aimovig (erenumab), emgality (galcanezumab), and ajovy (fremanezumab)
In terms of medication, aimovig and emgality are injected subcutaneously once a month, ajovy can be injected subcutaneously once a month or once every three months, which is more convenient in terms of medication and will provide patients with a differentiated treatment option
In addition to the three antibody drugs mentioned above, the single antibody drug eptinezumab (intravenous infusion once every three months) of alder company has been reviewed in the United States and is expected to be approved in early 2020, with a high response rate of 100% in some patients
In September 2019, Lingbei acquired alder with USD 1.95 billion
It is worth mentioning that Lilly emgality was also approved by the US FDA in June 2019 as a new indication for the treatment of adult onset cluster migraine (ECH)
This approval makes emgality the first and only drug to treat ECH
It is also the first and only CGRP targeted antibody approved by FDA to treat two different headache diseases
For TIWA, based on the analysis of ineffectiveness, the company announced in April 2019 to terminate the phase III clinical project of ajov in the treatment of cluster headache
At present, some companies are developing oral CGRP inhibitors
In December 2019, ubrogepant was approved by FDA for acute treatment of adult migraine (with or without aura)
It is worth mentioning that ubralvy is the first and only oral calcitonin gene-related peptide (CGRP) receptor antagonist approved by FDA for the treatment of migraine attack
In addition to ubralvy, Aerjian also has an oral CGRP receptor antagonist, atogepant, which has been developed to prevent migraine
In addition, biohaven also has an oral CGRP receptor antagonist zydis (rimegepant orally disintegrating tablet), which is under review by the US FDA and is expected to be approved in early 2020
In terms of acute treatment of migraine, in mid October 2019, leyvow (lashiditan) was approved by the US FDA for acute treatment of adult migraine (with or without aura symptoms)
The approval is significant because reyvow represents the first new class of acute migraine drugs approved by FDA in more than 20 years
It should be noted that reyvow is not suitable for the prophylactic treatment of migraine
The dosage specifications of the drug are 50mg, 100mg and 200mg, which can be selected according to the needs
The active component of reyvow is lasmiditan, which is an oral, central nervous system permeable, selective, 5-hydroxytryptamine 1F (5-HT1F) agonist
It is different from the currently approved migraine drug in structure and mechanism, and has no vasoconstrictive activity
It is worth mentioning that lasmiditan is the first and only drug molecule approved for acute treatment of migraine in adults
This approval represents the first major innovation in the treatment of acute migraine in more than 20 years
Original source: Teva announcements FDA approval of ajovy (fremanezumab vfrm) injection autoinjector
