Eli Lilly and Company — Rayvow EMA EPAR public assessment report (EMEA/H/C/005332, 2022)

Eli Lilly and Company · 2022 · EMA EPAR public assessment report · company profile →

Report summary

This EMA report details the assessment of Rayvow (lasmiditan) for acute migraine treatment in adults, leading to a positive marketing authorization opinion. Lasmiditan, a selective 5-HT1F receptor agonist, demonstrated superior efficacy over placebo in achieving pain freedom and freedom from most bothersome symptoms at 2 hours post-dose across multiple Phase 3 trials (50mg, 100mg, 200mg doses). Its non-clinical profile showed high 5-HT1F selectivity and lack of vasoconstrictive effects, differentiating it from triptans. Safety data revealed common, dose-dependent CNS depressant adverse events like dizziness and somnolence, and a significant driving impairment effect. Despite these, and some abuse potential, the overall benefit-risk assessment was favorable, with no significant long-term safety concerns identified.

Key findings — cited to the page

NOEC (Daphnia magna Reproduction Test)	2700 µg/L	· p.38
Hypoaesthesia (Phase 2/3 Pool)	2.3 %	· p.128
Active substance	LASMIDITAN SUCCINATE	· p.2
Strengths	50 mg, 100 mg and 200 mg	· p.2
Marketing authorisation application submission date	6 November 2020	RAYVOW · p.8
Asthenia (Phase 2/3 Pool, placebo)	0.2 %	· p.128
ATC Code	N02CC	· p.2
International Non-proprietary Name	lasmiditan	· p.2
Therapeutic indication	acute treatment of the headache phase of migraine attacks, with or without aura in adults	Rayvow · p.2
Procedure number	EMEA/H/C/005332/0000	RAYVOW · p.1
Applicant	Eli Lilly Nederland B.V.	NETHERLANDS · p.2
Route of administration	Oral use	· p.2

Source: Eli Lilly and Company ↗ · 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 →