H. Lundbeck A/S — Vyepti FDA Review (BLA761119, ORIG 1, 2020)
H. Lundbeck A/S · 2020 · FDA Review (openFDA) · company profile →
Report summary
The FDA clinical review recommends approval for Vyepti (eptinezumab) at 100 mg and 300 mg doses for adult migraine prevention. Two pivotal studies (006 and 011) demonstrated significant reductions in monthly migraine days and improved responder rates for both episodic and chronic migraine, with a rapid onset of effect and quarterly intravenous administration. While generally well-tolerated, safety concerns include hypersensitivity reactions leading to discontinuation, and slight imbalances in suicidal behaviors and constipation, warranting enhanced pharmacovigilance. No significant liver toxicity or neurologic safety signals were identified, but a warning for hypersensitivity and a pregnancy registry are recommended.
Key findings — cited to the page
| Discontinuation due to Adverse Event (Epti 30 mg) | 11 | · p.98 |
| Early Study Discontinuation due to Study Burden (Epti 30 mg) | 24 | · p.98 |
| Early Study Discontinuation due to Study Burden (Epti 100 mg) | 19 | · p.98 |
| Early Study Discontinuation due to Adverse Event (All Epti Pivotal) | 12 | · p.98 |
| Early Study Discontinuation due to Study Burden (Placebo) | 24 | · p.98 |
| Early Study Discontinuation due to Study Burden (All Epti Pivotal) | 44 | · p.98 |
| Early Study Discontinuation due to Lack of Efficacy (Epti 30 mg) | 18 | · p.98 |
| Migraine diagnosis age | 50 years of age | · p.31 |
| History of migraine | 12 months | · p.31 |
| Early Study Discontinuation due to Study Burden (Epti 300 mg) | 13 | · p.98 |
| Mean change from baseline in monthly migraine days | -4.29 | Study 006 · p.50 |
| Mean difference from placebo in monthly migraine days | -1.11 | Study 006 · p.50 |
Source: H. Lundbeck A/S ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Neurology library →