Kyntheum(brodalumab)

Immunology· 737 cited findings· 1 source document

Company: LEO A S

What the regulatory reviews say

Kyntheum (brodalumab) is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy. It was granted a positive opinion for marketing authorization on 18 May 2017, following a procedure that started on 4 December 2015. Brodalumab is considered a new active substance.

Efficacy results show that patients treated with brodalumab achieved significant improvements in Psoriasis Area and Severity Index (PASI) scores. PASI 75 responders ranged from 33.3% to 82.5%, and PASI 90 responders ranged from 17.9% to 75.0%. PASI 100 responders were reported as 0% in some instances. The overall PASI improvement percentages ranged from 16.0% to 86.3%.

Safety data from 4461 patients exposed to brodalumab, with a total of 5448.8 subject-years of exposure, indicate an incidence of arthralgia at 2.4%. Infections and Infestations System Organ Class (SOC) incidence ranged from 22.8% to 27.5%. The exposure-adjusted rate for upper respiratory tract infection was between 19.2 and 25.3 per 100 subject-years.

Key figures — cited to the source page

PASI 75 responders (%)	82.5	LEO A S — Kyntheum EMA EPAR public assessment report (EMEA/H, p.39
PASI 90 responders (%)	75.0	LEO A S — Kyntheum EMA EPAR public assessment report (EMEA/H, p.39
PASI improvement (%)	86.3	LEO A S — Kyntheum EMA EPAR public assessment report (EMEA/H, p.39
Number of patients exposed to brodalumab	4461	LEO A S — Kyntheum EMA EPAR public assessment report (EMEA/H, p.96
Total subject-years exposed to brodalumab	5448.8	LEO A S — Kyntheum EMA EPAR public assessment report (EMEA/H, p.96
Incidence of arthralgia (%)	2.4	LEO A S — Kyntheum EMA EPAR public assessment report (EMEA/H, p.99
Infections and Infestations SOC incidence	27.5	LEO A S — Kyntheum EMA EPAR public assessment report (EMEA/H, p.100
Positive opinion for marketing authorisation date	18 May 2017	LEO A S — Kyntheum EMA EPAR public assessment report (EMEA/H, p.8

Source documents

LEO A S — Kyntheum EMA EPAR public assessment report (EMEA/H/C/003959, 2017) (2017)

Explore the full evidence

All 737 cited findings for Kyntheum — searchable, comparable and answerable in plain language — are in the Immunology research library →

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.