Aquipta
Neurology· 616 cited findings· 1 source document
Company: AbbVie Inc. →
What the regulatory reviews say
Aquipta (atogepant) is indicated for the prophylaxis of migraine in adults who experience at least 4 migraine days per month. The marketing authorization application was submitted on June 24, 2022, with a positive opinion from the CHMP issued on June 22, 2023. Atogepant was approved in the US on September 28, 2021.
In clinical trials, atogepant demonstrated a significant reduction in monthly migraine days. For example, atogepant 60 mg QD resulted in a change from baseline of -4.14 monthly migraine days, compared to -2.47 for placebo. The least squares mean difference (LSMD) for atogepant 60 mg QD versus placebo was -1.66 monthly migraine days (p <.0001). Additionally, 42.1% of subjects treated with atogepant achieved a >=50% reduction in the 3-month average of monthly migraine days.
Common adverse events included constipation and nausea. Constipation incidence ranged from 6.1% (atogepant 10 mg QD) to 9.0% (atogepant 30 mg BID), compared to 2.0% in the placebo group. Nausea incidence ranged from 5.1% (atogepant 10 mg QD) to 9.0% (atogepant 60 mg QD), compared to 3.3% in the placebo group. The recommended lowest dose of atogepant with strong CYP3A4 inhibitors is 10 mg.
Key figures — cited to the source page
| LSMD (atogepant 60 mg QD vs. placebo) for monthly migraine days | -1.66 | AbbVie Inc. — Aquipta EMA EPAR public assessment report (EME, p.81 |
| Adjusted p-value for atogepant 60 mg QD vs. placebo for monthly migraine days | <.0001 | AbbVie Inc. — Aquipta EMA EPAR public assessment report (EME, p.81 |
| Percentage of subjects with >=50% reduction in 3-month average of monthly MDs | 42.1% | AbbVie Inc. — Aquipta EMA EPAR public assessment report (EME, p.91 |
| Constipation incidence in atogepant 60 mg QD group | 7.5 | AbbVie Inc. — Aquipta EMA EPAR public assessment report (EME, p.96 |
| Constipation incidence in placebo group | 2.0 | AbbVie Inc. — Aquipta EMA EPAR public assessment report (EME, p.96 |
| Nausea incidence in atogepant 60 mg QD group | 9.0 | AbbVie Inc. — Aquipta EMA EPAR public assessment report (EME, p.96 |
| Nausea incidence in placebo group | 3.3 | AbbVie Inc. — Aquipta EMA EPAR public assessment report (EME, p.96 |
| CHMP positive opinion for marketing authorisation | 22 June 2023 | AbbVie Inc. — Aquipta EMA EPAR public assessment report (EME, p.9 |
Source documents
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.