Skilarence(dimethylfumarate)

Immunology· 333 cited findings· 1 source document

Company: Almirall S A

What the regulatory reviews say

Skilarence (dimethylfumarate) is indicated for the treatment of moderate to severe plaque psoriasis in adults in need of systemic medicinal therapy. The Marketing Authorisation Application was submitted on 2 December 2015, with a positive opinion from the CHMP issued between 18-21 April 2017. The legal basis for the application was Article 8(3) of Directive 2001/83/EC, representing a complete and independent application.

In clinical trials, Skilarence demonstrated efficacy with PASI 75 response rates ranging from 37.5% to 42.7%. The difference in PASI 75 responder proportions between Skilarence and placebo was 22.2% and 22.8%. For PGA clear/almost clear response rates, values ranged from 32.5% to 39.5%, with a difference in PGA responder proportions versus placebo of 19.9% and 20.0%. A notable safety finding is that 89% to 100% of patients reported adverse events. Skilarence is contraindicated in pregnancy.

Key figures — cited to the source page

PASI 75 response rate (Skilarence)	42.7	Almirall S A — Skilarence EMA EPAR public assessment report, p.60
Difference in PASI 75 responder proportions (Skilarence vs. Placebo)	22.8	Almirall S A — Skilarence EMA EPAR public assessment report, p.60
PGA clear/almost clear response rate (Skilarence)	39.5	Almirall S A — Skilarence EMA EPAR public assessment report, p.60
Difference in PGA responder proportions (Skilarence vs. Placebo)	20.0	Almirall S A — Skilarence EMA EPAR public assessment report, p.60
Patients reporting AEs	100	Almirall S A — Skilarence EMA EPAR public assessment report, p.65
CHMP positive opinion date	18-21 April 2017	Almirall S A — Skilarence EMA EPAR public assessment report, p.7
Marketing Authorisation Application submission date	2 December 2015	Almirall S A — Skilarence EMA EPAR public assessment report, p.6
Contraindication in pregnancy	Skilarence is contra-indicated in pregnancy	Almirall S A — Skilarence EMA EPAR public assessment report, p.23

Source documents

Almirall S A — Skilarence EMA EPAR public assessment report (EMEA/H/C/002157, 2017) (2017)

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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.