Ontozry

Neurology· 687 cited findings· 1 source document

Company: Angelini Pharma

What the regulatory reviews say

Ontozry is indicated for the treatment of focal-onset seizures in adults. In clinical trials, the responder rate (>=50% reduction in seizure frequency) ranged from 40.7% to 60.4%. For patients receiving 100 mg/day, 42% experienced a >50% reduction in seizure frequency, increasing to 52% at 200 mg/day and 60% at 400 mg/day. The fraction of seizure-free patients was 13% at 100 mg/day, 20% at 200 mg/day, and 28% at 400 mg/day.

Safety findings included a largest mean change from baseline heart rate of -2.9 bpm with 500 mg cenobamate and a largest mean change-from-baseline QTcF of -22.5 msec with 500 mg cenobamate. The mean placebo-corrected ΔΔQTcF was -18.4 msec for 500 mg cenobamate. Nine subjects experienced QTcF ≥450 ms. The Marketing Authorisation Application was submitted on 9 March 2020, and a CHMP positive opinion was issued on 28 January 2021.

Key figures — cited to the source page

Responder rate (>=50% reduction in seizure frequency)	60.4	Angelini S p A — Ontozry EMA EPAR public assessment report (, p.82
Fraction of patients with >50% reduction in seizure frequency (400 mg/day)	0.60	Angelini S p A — Ontozry EMA EPAR public assessment report (, p.62
Fraction of seizure-free patients (400 mg/day)	0.28	Angelini S p A — Ontozry EMA EPAR public assessment report (, p.62
Largest mean change-from-baseline QTcF (500 mg cenobamate)	-22.5	Angelini S p A — Ontozry EMA EPAR public assessment report (, p.58
Mean placebo-corrected ΔΔQTcF (500 mg cenobamate)	-18.4	Angelini S p A — Ontozry EMA EPAR public assessment report (, p.58
Subjects with QTcF ≥450 ms	9	Angelini S p A — Ontozry EMA EPAR public assessment report (, p.58
Marketing Authorisation Application submission date	9 March 2020	Angelini S p A — Ontozry EMA EPAR public assessment report (, p.7
CHMP positive opinion date	28 January 2021	Angelini S p A — Ontozry EMA EPAR public assessment report (, p.8

Source documents

Angelini S p A — Ontozry EMA EPAR public assessment report (EMEA/H/C/005377, 2021) (2021)

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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.