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Atogepant - New Product Evaluation

Atogepant is an orally administered CGRP receptor antagonist developed for the preventive treatment of migraine, currently in Phase III trials in the USA and Europe. It works by blocking the CGRP receptor to prevent migraine attacks, showing significant efficacy and safety in clinical trials. The drug addresses an unmet need in migraine treatment by altering the pathophysiology associated with migraine, unlike conventional drugs.

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10 views4 pages

Atogepant - New Product Evaluation

Atogepant is an orally administered CGRP receptor antagonist developed for the preventive treatment of migraine, currently in Phase III trials in the USA and Europe. It works by blocking the CGRP receptor to prevent migraine attacks, showing significant efficacy and safety in clinical trials. The drug addresses an unmet need in migraine treatment by altering the pathophysiology associated with migraine, unlike conventional drugs.

Uploaded by

akshay21111985
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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Atogepant

(Company name – Allergan)


Migraine
Migraine is the second most cause of headache and the most common headache related and
neurologic cause of disability in the world. It is a common chronic headache disorder which is
characterized by the recurrent attacks which lasts from 4-72 hours, with a pulsating quality. Its
intensity includes as mild, moderate and severe. A number of intrinsic or extrinsic factors can trigger
migraine attack like environmental, dietary, or physiologic factor.1

Pathogenesis2

Pathophysiology of migraine has not yet been fully elucidated. However, activation of the trigemino
vascular system is involved: Branches of the trigeminal nerve innervate the face and parts of the
meninges, including intracranial blood vessels and the dura; the perivascular trigeminal branches
release several neuropeptides, including calcitonin-gene related peptide (CGRP); trigeminal CGRP
release induces cranial vasodilation which, in turn, may activate nociceptors on the trigeminal nerve,
and this is eventually followed by pain perception;

Prevalence3

Worldwide three billion individuals were estimated to have a migraine or tension-type headache in
2016: 1.89 billion with tension-type headache and 1.04 billion with migraine.

The prevalence is highest in some part of Europe, Australia and India.

Fig 1 - Figure 1: Global prevalence of Migraine

Standard of care4
Atogepant5, 6, 7

Atogepant is an orally administered, CGRP receptor antagonist specifically developed for the
preventive treatment of migraine. CGRP and its receptors are expressed in regions of the nervous
system associated with migraine pathophysiology. Studies have shown that CGRP levels are elevated
during migraine attacks and selective CGRP receptor antagonists confer clinical benefit in migraine.

 In which phase the molecule is in –


USA & Europe

Sr no. Trial phase Condition or disease


1 Phase III Episodic Migraine Prevention

 Mechanism of action: CGRP is a pain related neuropeptide released during migraine attack,
Atogepant blocks the CGRP receptor and prevent the migraine attack.
 Approved Indication in EU & US Atogepant Not approved
 Dosage and administration: 10 - 60 mg once daily (dose as per the phase III trial)
 Indications in pipeline (under study) and off – label indications: NA
 Packaging details: NA
 Storage and Shelf life details: NA
 Unmet need / Medical Rationale for the Product: As per the pathophysiology of migraine
CGRP plays a vital role in the mechanism of migraine, conventional drugs do not have any direct
role or they do not alter the pathophysiology of the migraine. Atogepant is a CGRP receptor
blocker it inhibits calcitonin gene-related peptide-dependent vasodilatory responses in intracranial
arteries and thereby alters the pathophysiology for the prevention of migraine.
 Guidelines recommendations: NA
 Summary / tabulation of clinical trials:
 Clinical trial8:
Study design: Phase 2b/3, Prospective, double blind, Multicenter, Randomized, Double-Blind,
Placebo Controlled, Parallel-Group Study in 834 patients.
Title: To evaluate the efficacy safety and tolerability of multiple dosing regimens of oral atogepant in
episodic migration prevention.

Patients received placebo or atogepant 10 mg once daily, 30 mg once daily, 60 mg once daily, 30 mg
twice daily, or 60 mg twice daily,

Result:

1. Across the 12-weektreatment period, all five atogepant groups showed significant least-squares
mean change from baseline in mean monthly migraine days versus placebo
2. The most common treatment-emergent adverse events across all groups were nausea and
fatigue.

Conclusion: All doses of oral atogepant were associated with a significant decrease in monthly
migraine days over12 weeks compared with placebo. Atogepant was safe and well tolerated over 12
weeks, supporting its phase 3 development for the preventive treatment of migraine.
On Going Trials9
1. Clinical trial

A Phase 3, Multicenter, Randomized, Double-blind, Placebo controlled, Parallel-group Study to


Evaluate the Efficacy, Safety, and Tolerability of Oral Atogepant for the Prophylaxis of Migraine in
Participants with Episodic Migraine Who Have Previously Failed 2 to 4 Classes of Oral Prophylactic
Treatments.

2. Clinical trial
A phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate
the efficacy, safety, and tolerability of atogepant for the prevention of chronic migraine.

Medical team’s opinion on this molecule

Atogepant is an CGRP antagonist, it has direct effect on the pathophysiology of the migraine. The
safety efficacy and tolerability of the molecule looks promising as per the data available from the
phase III trials. The drug is devoid of vasoconstrictive effect in human coronary arteries.

Thus, depending on the drug profile and the clinical data available, the molecule can be considered
for further discussion.

References

1. Weatherall MW. The diagnosis and treatment of chronic migraine. Ther Adv Chronic Dis.
2015;6(3):115-123.
2. De Vries T et al. A. Pharmacological treatment of migraine: CGRP and 5-HT beyond the
triptans. Pharmacol Ther. 2020 Jul; 211:107528.
3. Stovner et al. Global, regional, and national burden of migraine and tension-type headache,
1990–2016: a systematic analysis for the Global Burden of Disease Study 2016. The Lancet
Neurology. 2018; 17:954-976.
4. https://www.aafp.org/afp/2019/0101/p17.html
5. https://news.abbvie.com/news/press-releases/abbvie-announces-positive-phase-3-data-for-
atogepant-in-migraine-prevention.htm
6. https://clinicaltrials.gov/ct2/show/NCT02848326
7. Durham PL, Vause CV. Calcitonin gene-related peptide (CGRP) receptor antagonists in the
treatment of migraine. CNS Drugs. 2010;24(7):539-548.
8. https://news.abbvie.com/news/press-releases/abbvie-announces-positive-phase-3-data-for-
atogepant-in-migraine-prevention.htm
9. https://pubchem.ncbi.nlm.nih.gov/compound/Atogepant#section=EU-Clinical-Trials-Register

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