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*For medical professionals only eptinezumab is the first and only intravenous drug approved in the EU for migraine prevention
.
Recently, H.
Lundbeck announced that the European Commission (EC) has approved the marketing authorization of eptinezumab for the prophylactic treatment of migraine in adult patients with migraine headaches at least 4 days per month
.
It is reported that eptinezumab is the first and only intravenous drug approved in the EU for the preventive treatment of migraine
.
1.
Migraine has a high disability rate and poor overall treatment effect.
Migraine is a common chronic neurovascular disease.
Its clinical manifestations are recurrent, unilateral or bilateral, pulsatile, moderate to Severe headache
.
According to the 2017 Global Burden of Disease Survey, migraine is the second most disabling disease in terms of years of life lost due to disability
.
In recent years, the global incidence of migraine is 8.
4% to 28%.
The incidence of migraine is higher in women than in men, and the accompanying symptoms are more severe, and headache-related physical disorders are more common
.
Pharmacological treatment of migraine includes two aspects: treatment of acute attacks and preventive treatment
.
In the acute phase, the principle of rapid and continuous analgesia and reduction of headache recurrence are the principles.
Commonly used drugs include non-steroidal anti-inflammatory drugs (ibuprofen, diclofenac, etc.
), triptans and ergotamines
.
Preventive treatment of migraine should be considered when daily life and work are seriously affected, the frequency of attacks is twice or more per month, the response to pain medication is ineffective in the acute phase, or when there are severe and frequent auras
.
Currently, migraine preventive treatment drugs include antiepileptic drugs, calcium channel blockers, beta-receptor antagonists, antidepressants and other drugs, however, most of these drugs are not specific for migraine and may cause serious adverse reactions and poor efficacy
.
2eptinezumab is an anti-CGRP monoclonal antibody calcitonin-gene-related peptide (CGRP), a sensory neuropeptide consisting of 37 amino acids, involved in neurogenic inflammation, peripheral and central sensitization and cortical spreading depression process that modulates and induces migraine
.
Numerous studies have shown that activation of the trigeminal nerve-vascular system is the structural basis for throbbing headache and its accompanying symptoms in migraine.
In neurogenic inflammation, CGRP is released from trigeminal nerve pain fiber terminals, mediating vasodilation, increasing blood flow, and increasing blood flow.
Increase the release of substance P, promote plasma extravasation and induce edema; at the same time recruit mast cells, glial cells, etc.
, to release inflammatory mediators, resulting in neurogenic inflammation, leading to migraine attacks [1]
.
The new drug eptinezumab developed by H.
Lundbeck is a humanized anti-CGRP monoclonal antibody, which can specifically bind to CGRP released from trigeminal nerve terminals and block its binding to endogenous receptors as a ligand, thereby reducing bias The occurrence of headaches
.
The incidence of adverse reactions of eptinezumab is extremely low, which may be related to the high selectivity and target specificity of eptinezumab itself; and as the first anti-migraine antibody drug administered by intravenous injection, eptinezumab can be in the blood Therapeutic levels are reached immediately, with efficacy on the day of infusion
.
3 The efficacy and safety of eptinezumab have been confirmed in phase III clinical trials The approval of the new drug eptinezumab is based on positive findings from two phase III clinical trials (PROMISE-1[2] and PROMISE-2[3])
.
The two studies were randomized, double-blind, multicenter, placebo-controlled studies (NCT02559895 and NCT02974153) that evaluated the efficacy and safety of eptinezumab in episodic and chronic migraine, respectively
.
The primary endpoint was change from baseline in mean monthly migraine days (MMD) over 1-3 months
.
Figure 1: PROMISE-2 Trial Primary Endpoint Both studies met the trial's primary and key secondary endpoints
.
The results of the PROMISE-2 trial showed that compared with the placebo group, MMD was reduced by 7.
7 days in the eptinezumab 100 mg group (P < 0.
0001) and 8.
2 days in the eptinezumab 300 mg group (P < 0.
0001) within 1 to 12 weeks (Figure 1).
)
.
Notably, two doses (100 mg and 300 mg) of eptinezumab showed therapeutic benefit on the first day after intravenous infusion, reducing the incidence of migraine by 50%, and those who experienced a migraine attack most of the first 7 days.
The proportion of patients was significantly lower than in the placebo group (Figure 2) [3]
.
Figure 2: Secondary endpoints of the PROMISE-2 trial.
In terms of safety, eptinezumab was generally tolerated in patients with episodic and chronic migraine.
According to the data from PROMISE-1 and PROMISE-2, the most common adverse reactions were Nasopharyngitis (100mg: 6%, 300mg: 8% vs placebo: 6%) and hypersensitivity reactions such as angioedema, urticaria, facial flushing and rash (100mg: 1%, 300mg: 2% vs placebo: 0 %)
.
In these two clinical trials, 1.
9% of patients treated with eptinezumab discontinued treatment due to adverse reactions [3]
.
As the world's first and currently the only intravenous drug for migraine, eptinezumab has the advantages of long dosing interval, high patient compliance, and good safety, providing a valuable supplement for the treatment of migraine
.
However, due to the limited clinical data at present, the safety of this product for patients and the usage and dosage of special populations need further research to confirm
.
References: [1] Zhao Xiuyuan, Xu Xiaolin.
Calcitonin gene-related peptide and migraine.
International Journal of Neurology and Neurosurgery, 2019.
46(1):5.
[2] Ashina, M.
, et al.
, Eptinezumab in episodic migraine: A randomized, double-blind, placebo-controlled study (PROMISE-1).
Cephalalgia, 2020.
40(3): p.
241-254.
[3] Lipton, RB, et al.
, Efficacy and safety of eptinezumab in patients with chronic migraine: PROMISE-2.
Neurology, 2020.
94(13):p.
e1365-e1377.
.
Recently, H.
Lundbeck announced that the European Commission (EC) has approved the marketing authorization of eptinezumab for the prophylactic treatment of migraine in adult patients with migraine headaches at least 4 days per month
.
It is reported that eptinezumab is the first and only intravenous drug approved in the EU for the preventive treatment of migraine
.
1.
Migraine has a high disability rate and poor overall treatment effect.
Migraine is a common chronic neurovascular disease.
Its clinical manifestations are recurrent, unilateral or bilateral, pulsatile, moderate to Severe headache
.
According to the 2017 Global Burden of Disease Survey, migraine is the second most disabling disease in terms of years of life lost due to disability
.
In recent years, the global incidence of migraine is 8.
4% to 28%.
The incidence of migraine is higher in women than in men, and the accompanying symptoms are more severe, and headache-related physical disorders are more common
.
Pharmacological treatment of migraine includes two aspects: treatment of acute attacks and preventive treatment
.
In the acute phase, the principle of rapid and continuous analgesia and reduction of headache recurrence are the principles.
Commonly used drugs include non-steroidal anti-inflammatory drugs (ibuprofen, diclofenac, etc.
), triptans and ergotamines
.
Preventive treatment of migraine should be considered when daily life and work are seriously affected, the frequency of attacks is twice or more per month, the response to pain medication is ineffective in the acute phase, or when there are severe and frequent auras
.
Currently, migraine preventive treatment drugs include antiepileptic drugs, calcium channel blockers, beta-receptor antagonists, antidepressants and other drugs, however, most of these drugs are not specific for migraine and may cause serious adverse reactions and poor efficacy
.
2eptinezumab is an anti-CGRP monoclonal antibody calcitonin-gene-related peptide (CGRP), a sensory neuropeptide consisting of 37 amino acids, involved in neurogenic inflammation, peripheral and central sensitization and cortical spreading depression process that modulates and induces migraine
.
Numerous studies have shown that activation of the trigeminal nerve-vascular system is the structural basis for throbbing headache and its accompanying symptoms in migraine.
In neurogenic inflammation, CGRP is released from trigeminal nerve pain fiber terminals, mediating vasodilation, increasing blood flow, and increasing blood flow.
Increase the release of substance P, promote plasma extravasation and induce edema; at the same time recruit mast cells, glial cells, etc.
, to release inflammatory mediators, resulting in neurogenic inflammation, leading to migraine attacks [1]
.
The new drug eptinezumab developed by H.
Lundbeck is a humanized anti-CGRP monoclonal antibody, which can specifically bind to CGRP released from trigeminal nerve terminals and block its binding to endogenous receptors as a ligand, thereby reducing bias The occurrence of headaches
.
The incidence of adverse reactions of eptinezumab is extremely low, which may be related to the high selectivity and target specificity of eptinezumab itself; and as the first anti-migraine antibody drug administered by intravenous injection, eptinezumab can be in the blood Therapeutic levels are reached immediately, with efficacy on the day of infusion
.
3 The efficacy and safety of eptinezumab have been confirmed in phase III clinical trials The approval of the new drug eptinezumab is based on positive findings from two phase III clinical trials (PROMISE-1[2] and PROMISE-2[3])
.
The two studies were randomized, double-blind, multicenter, placebo-controlled studies (NCT02559895 and NCT02974153) that evaluated the efficacy and safety of eptinezumab in episodic and chronic migraine, respectively
.
The primary endpoint was change from baseline in mean monthly migraine days (MMD) over 1-3 months
.
Figure 1: PROMISE-2 Trial Primary Endpoint Both studies met the trial's primary and key secondary endpoints
.
The results of the PROMISE-2 trial showed that compared with the placebo group, MMD was reduced by 7.
7 days in the eptinezumab 100 mg group (P < 0.
0001) and 8.
2 days in the eptinezumab 300 mg group (P < 0.
0001) within 1 to 12 weeks (Figure 1).
)
.
Notably, two doses (100 mg and 300 mg) of eptinezumab showed therapeutic benefit on the first day after intravenous infusion, reducing the incidence of migraine by 50%, and those who experienced a migraine attack most of the first 7 days.
The proportion of patients was significantly lower than in the placebo group (Figure 2) [3]
.
Figure 2: Secondary endpoints of the PROMISE-2 trial.
In terms of safety, eptinezumab was generally tolerated in patients with episodic and chronic migraine.
According to the data from PROMISE-1 and PROMISE-2, the most common adverse reactions were Nasopharyngitis (100mg: 6%, 300mg: 8% vs placebo: 6%) and hypersensitivity reactions such as angioedema, urticaria, facial flushing and rash (100mg: 1%, 300mg: 2% vs placebo: 0 %)
.
In these two clinical trials, 1.
9% of patients treated with eptinezumab discontinued treatment due to adverse reactions [3]
.
As the world's first and currently the only intravenous drug for migraine, eptinezumab has the advantages of long dosing interval, high patient compliance, and good safety, providing a valuable supplement for the treatment of migraine
.
However, due to the limited clinical data at present, the safety of this product for patients and the usage and dosage of special populations need further research to confirm
.
References: [1] Zhao Xiuyuan, Xu Xiaolin.
Calcitonin gene-related peptide and migraine.
International Journal of Neurology and Neurosurgery, 2019.
46(1):5.
[2] Ashina, M.
, et al.
, Eptinezumab in episodic migraine: A randomized, double-blind, placebo-controlled study (PROMISE-1).
Cephalalgia, 2020.
40(3): p.
241-254.
[3] Lipton, RB, et al.
, Efficacy and safety of eptinezumab in patients with chronic migraine: PROMISE-2.
Neurology, 2020.
94(13):p.
e1365-e1377.
