Novartis AG — Aimovig EMA EPAR variation assessment report (EMEA/H/C/004447, 2018)
Novartis AG · 2018 · EMA EPAR variation assessment report · company profile →
Report summary
This report summarizes the assessment of a variation to Aimovig's marketing authorization, introducing a new 140 mg strength in pre-filled syringe and autoinjector pen formats. Bioequivalence was established between the 140 mg PFS and two 70 mg PFS injections, with extrapolation to the autoinjector. No new efficacy studies were needed as the posology is unchanged. Safety data from two Phase 1 studies confirmed a consistent safety profile with the original application, identifying no new concerns. Common adverse events included injection site reactions and constipation. The report recommends approval of the 140 mg strength.
Key findings — cited to the page
| CTCAE grade 3 or above lab values | 4 subjects | Study 20160442 · p.18 |
| creatine phosphokinase elevation (Grade 3 or 4) | 5 subjects | Studies 20160349 and 20160442 · p.20 |
| CTCAE grade 3 or above lab values | 7 subjects | Study 20160349 · p.18 |
| Binding antibodies against erenumab-aooe (1x140mg PFS group) | 15.8 % | · p.13 |
| Incidence of ADAs (original MAA, 70mg dose) | 6.3 % | · p.14 |
| Incidence of ADAs (original MAA, 140mg dose) | 2.6 % | · p.14 |
| Binding antibodies against erenumab-aooe (Study 20160349) | 16.9 % | · p.13 |
| Study 20160349 subjects receiving 1x140mg SC injection | 105 subjects | · p.14 |
| Study 20160349 subjects receiving 2x70mg SC injections | 106 subjects | · p.14 |
| Neutralizing antibodies against erenumab-aooe (Study 20160349) | 0.5 % | · p.13 |
| Incidence of ADAs (Study 20160349) | 17.9 % | · p.14 |
| Binding antibodies against erenumab-aooe (2x70mg PFS group) | 17.9 % | · p.13 |
Source: Novartis AG ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Neurology library →