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News March 30, 2021 /bioon.
com" target="_blank">/ --AbbVie recently announced that the U.
S.
Food and Drug Administration (FDA) has accepted atogepant's New Drug Application (NDA) for adult patients who meet the criteria for episodic migraine (EM) for migraine Preventive treatment.
AbbVie expects that the bioon.
com/fda/" target="_blank">FDA will make a regulatory decision by the end of the third quarter of 2021.
If approved, atogepant will be the first and only oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) specifically developed for the preventive treatment of migraine, which will provide patients with a simple, daily A safe and effective preventive treatment drug that is taken orally once.
bioon.com" target="_blank">/ --AbbVie recently announced that the U.
S.
Food and Drug Administration (FDA) has accepted atogepant's New Drug Application (NDA) for adult patients who meet the criteria for episodic migraine (EM) for migraine Preventive treatment.
AbbVie expects that the bioon.
com/fda/" target="_blank">FDA will make a regulatory decision by the end of the third quarter of 2021.
If approved, atogepant will be the first and only oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) specifically developed for the preventive treatment of migraine, which will provide patients with a simple, daily A safe and effective preventive treatment drug that is taken orally once.
com" target="_blank">bioon.
com/fda/" target="_blank">FDA
Migraine is a complex chronic disease.
Its onset usually causes the patient to lose the ability to live or work normally.
It can include severe head pain and neurological and autonomic symptoms.
The symptoms and severity of migraines vary greatly among individuals.
Migraine attacks can be debilitating, but migraine is a treatable disease.
Migraine attacks can be debilitating, but migraine is a treatable disease.Its onset usually causes the patient to lose the ability to live or work normally.
It can include severe head pain and neurological and autonomic symptoms.
The symptoms and severity of migraines vary greatly among individuals.
Migraine attacks can be debilitating, but migraine is a treatable disease.
Atogepant is an oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant), specially developed for the preventive treatment of migraine.
CGRP and its receptors are expressed in areas of the nervous system related to the pathophysiology of migraine.
Studies have shown that CGRP levels increase during migraine attacks, and selective CGRP receptor antagonists have clinical effects on migraine.
CGRP and its receptors are expressed in areas of the nervous system related to the pathophysiology of migraine.
Studies have shown that CGRP levels increase during migraine attacks, and selective CGRP receptor antagonists have clinical effects on migraine.
atogepant NDA is based on a strong clinical project data support.
The project was carried out in nearly 2500 patients with migraine 4-14 days per month, and evaluated the efficacy, safety and tolerability of oral atogepant for migraine preventive treatment.
The project included the key Phase 3 ADVANCE study, key Phase 2b/3 study (CGP-MD-01) and Phase 3 long-term safety study.
The project was carried out in nearly 2500 patients with migraine 4-14 days per month, and evaluated the efficacy, safety and tolerability of oral atogepant for migraine preventive treatment.
The project included the key Phase 3 ADVANCE study, key Phase 2b/3 study (CGP-MD-01) and Phase 3 long-term safety study.
Data from the Phase 3 ADVANCE study showed that during the 12-week treatment period, compared with placebo, all doses (10mg, 30mg, 60mg) of atogepant significantly reduced the average monthly migraine days from baseline.
In addition, the two high doses (30mg, 60mg) showed statistically significant improvement in all six secondary endpoints.
In addition, the two high doses (30mg, 60mg) showed statistically significant improvement in all six secondary endpoints.
In the field of migraine, AbbVie is selling BOTOX (Botox®, botulinum toxin A, onabotulinumtoxinA) and Ubrelvy (ubrogepant).
Among them, BOTOX is the first preventive drug for adult chronic migraine approved by the US FDA, and Ubrelvy is the first oral CGRP receptor antagonist (gepant) approved by the bioon.
com/fda/" target="_blank">FDA for adult migraine (with or without aura) ) Acute treatment.
bioon.Among them, BOTOX is the first preventive drug for adult chronic migraine approved by the US FDA, and Ubrelvy is the first oral CGRP receptor antagonist (gepant) approved by the bioon.
com/fda/" target="_blank">FDA for adult migraine (with or without aura) ) Acute treatment.
com/fda/" target="_blank">FDA
Michael Gold, vice president of neuroscience development at AbbVie, said: "By integrating Allergan, AbbVie is now a firm leader in the field of migraine, with a history of nearly 25 years in migraine research.
We look forward to our A new treatment plan is added to the product portfolio, which will help more migraine patients.
We believe that as a safe and effective oral preventive treatment option, atogepant represents an advancement in migraine treatment and has the potential to provide Significant therapeutic benefits.
Although there are other migraine treatment options, the medical community and migraine sufferers recognize that the medical needs of patients with this unpredictable and debilitating disease are not met.
"
We look forward to our A new treatment plan is added to the product portfolio, which will help more migraine patients.
We believe that as a safe and effective oral preventive treatment option, atogepant represents an advancement in migraine treatment and has the potential to provide Significant therapeutic benefits.
Although there are other migraine treatment options, the medical community and migraine sufferers recognize that the medical needs of patients with this unpredictable and debilitating disease are not met.
"
Atogepant chemical structure (picture source: genome.
jp)
jp)
About the pivotal Phase III ADVANCE trial: ADVANCE is a multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase III trial designed to evaluate the effectiveness, safety and tolerability of oral atogepant in preventing migraine.
A total of 910 patients were randomly divided into 4 treatment groups, with 3 doses (10mg, 30mg, 60mg) of atogepant and placebo, orally once a day.
The efficacy analysis was based on a modified intention-to-treat (mITT) population of 873 patients.
Regarding the key Phase III ADVANCE trial:A total of 910 patients were randomly divided into 4 treatment groups, with 3 doses (10mg, 30mg, 60mg) of atogepant and placebo, orally once a day.
The efficacy analysis was based on a modified intention-to-treat (mITT) population of 873 patients.
The primary endpoint was the change in the average number of migraine days per month from baseline during the 12-week treatment period.
The data showed that all atogepant dose groups reached the primary endpoint, and the average number of migraine days per month was statistically significantly reduced compared with placebo.
The 10mg/30mg/60mg atogepant group reduced by 3.
69/3.
86/4.
2 days, and the placebo group reduced by 2.
48 days (compared with the placebo group in all dose groups, p≤0.
0001).
The data showed that all atogepant dose groups reached the primary endpoint, and the average number of migraine days per month was statistically significantly reduced compared with placebo.
The 10mg/30mg/60mg atogepant group reduced by 3.
69/3.
86/4.
2 days, and the placebo group reduced by 2.
48 days (compared with the placebo group in all dose groups, p≤0.
0001).
A key secondary endpoint measured the proportion of patients who had at least a 50% reduction in the number of migraine days per month during the 12-week treatment period.
The data showed that 55.
6%/58.
7%/60.
8% of the 10mg/30mg/60mg atogepant group were reduced by at least 50%, and the proportion of patients in the placebo group was 29.
0% (compared to the placebo group in all dose groups, p≤ 0.
0001).
The data showed that 55.
6%/58.
7%/60.
8% of the 10mg/30mg/60mg atogepant group were reduced by at least 50%, and the proportion of patients in the placebo group was 29.
0% (compared to the placebo group in all dose groups, p≤ 0.
0001).
Other secondary endpoints measured during the 12-week treatment period include: the monthly average headache days, the monthly average acute drug use days, the monthly average daily activity performance in the Migraine Diary Activity Impairment (AIM-D), and the physical impairment domain score from The change from baseline, and the change from baseline in the Migraine-Specific Quality of Life Questionnaire (MSQ) role functional restriction domain score at week 12.
The test showed that the 30 mg and 60 mg dose groups had statistically significant improvements in all secondary endpoints, while the 10 mg dose group had statistically significant improvements in 4 of the 6 secondary endpoints.
The test showed that the 30 mg and 60 mg dose groups had statistically significant improvements in all secondary endpoints, while the 10 mg dose group had statistically significant improvements in 4 of the 6 secondary endpoints.
In terms of safety, no new safety risks were observed compared with the safety observed in previous trials evaluating atogepant.
Serious adverse events occurred in 0.
9 patients in the 10 mg dose group and 0.
9% in the placebo group.
There were no serious adverse events in the 30 mg dose group and 60 mg dose group.
In at least one atogepant treatment group, the most common adverse events with a frequency of ≥5% and higher than placebo were constipation (6.
9-7.
7% in all dose groups, 0.
5% in placebo groups), nausea (4.
4 in all dose groups -6.
1%, 1.
8% in the placebo group) and upper respiratory tract infections (3.
9-5.
7% in all dose groups and 4.
5% in the placebo group).
Most cases of constipation, nausea, and upper suction tract infection were mild or moderate in severity and did not lead to discontinuation.
No liver safety issues were found in this trial.
Serious adverse events occurred in 0.
9 patients in the 10 mg dose group and 0.
9% in the placebo group.
There were no serious adverse events in the 30 mg dose group and 60 mg dose group.
In at least one atogepant treatment group, the most common adverse events with a frequency of ≥5% and higher than placebo were constipation (6.
9-7.
7% in all dose groups, 0.
5% in placebo groups), nausea (4.
4 in all dose groups -6.
1%, 1.
8% in the placebo group) and upper respiratory tract infections (3.
9-5.
7% in all dose groups and 4.
5% in the placebo group).
Most cases of constipation, nausea, and upper suction tract infection were mild or moderate in severity and did not lead to discontinuation.
No liver safety issues were found in this trial.
Regarding the Phase 2/3 CGP-MD-01 study: This study evaluated the efficacy, safety and tolerability of oral atogepant.
The data showed that all treatment groups of atogepant reached the primary endpoint.
During the 12-week treatment period, compared with placebo, the average number of migraine days per month was significantly reduced compared to baseline (10mg QD vs placebo, p=0.
0236; 30mg QD vs placebo P=0.
0390; 60mg QD vs placebo, p=0.
0390; 30mg BID vs placebo, p=0.
0034; 60mg BID vs placebo, p=0.
0031).
The results of the study were released in June 2018.
()
About the 2/3 CGP-MD-01 study:The data showed that all treatment groups of atogepant reached the primary endpoint.
During the 12-week treatment period, compared with placebo, the average number of migraine days per month was significantly reduced compared to baseline (10mg QD vs placebo, p=0.
0236; 30mg QD vs placebo P=0.
0390; 60mg QD vs placebo, p=0.
0390; 30mg BID vs placebo, p=0.
0034; 60mg BID vs placebo, p=0.
0031).
The results of the study were released in June 2018.
()
Original source: US bioon.
com/fda/" target="_blank">FDA Accepts AbbVie's New Drug app lication for Atogepant for the Preventive Treatment of Migraine
bioon. com/fda/" target="_blank">FDA Accepts AbbVie's New Drug app lication for Atogepant for the Preventive Treatment of Migraine
com/fda/" target="_blank">FDA app
