Dimethyl fumarate

24056811000001108

Articles

Medicine Compliance Aid Stability

Tecfidera · Biogen

Biogen
Tecfidera
Capsules e/c 120mg, 240mg
A3 · Amber 3 · No stability data is available. There are theoretical concerns with use in CAs, which may be mitigated by risk minimisation.
Protect from light
Protect from light
22nd September 2015

Lactation Safety Information

-
No published evidence of safety
Significant amounts anticipated in milk, although unlikely to accumulate in the infant due to the drugs properties
Monitor infant for flushing, abdominal pain, diarrhoea, and nausea
1st August 2017

New Medicines

Skilarence · Chronic plaque psoriasis, moderate-to-severe

Information

Skilarence
New formulation
Almirall
Not Known

Development and Regulatory status

Launched
Launched
None
July 2017

Jul 17: Skilarence is now available to order via wholesalers. NHS prices (excluding VAT) are: 30mg (42 tablets) - £89.04, 120 mg (90 tablets) - £190.80, 120mg (180 tablets) - £381.60 [11].


Jun 17: Almirall announces that the EC has approved the Marketing Authorisation for Skilarence in the treatment of patients with moderate-to-severe chronic plaque Psoriasis; the approval includes both first-line induction and long-term maintenance treatment. The company expects to market the product across the EU during Q3 2017 [10].


Apr 17: EU positive opinion for treatment of moderate to severe plaque psoriasis in adults in need of systemic medicinal therapy [9].


Jun 16: Listed as filed in Almirall pipeline[8].


Jan 16: Dimethyl fumarate for psoriasis listed in CHMP list of medicines under evaluation; assume this product has been filed via centralised procedure [7].


Sep 15: Listed as PIII in Almirall pipeline [5].


May 14: Likely to be filed via the EU decentralised procedure [3].

Category

Fumaric acid derivative. Skilarence will be available as 30-mg and 120-mg gastro-resistant tablets.
Prevalence is thought to vary among ethnic groups, with a higher prevalence among Scandinavian populations. Approximately 2% of Europeans have psoriasis: plaque psoriasis is the most common type, representing 90% of cases.
Chronic plaque psoriasis, moderate-to-severe
Oral

Further information

Yes
November 2017
https://www.nice.org.uk/guidance/indevelopment/gid-ta10096

Trial or other data

Dec 15: NCT01726933 completed in November 15 [6].


Jun 15: PIII study (NCT01726933) is ongoing but no longer recruiting pts. The study is expected to complete in Oct 15 [4].


May 14: The comparator in the PIII trial (EudraCT2012-000055-13; NCT01726933) is a licensed dimethyl fumarate tablet formulation (Fumaderm®). Results are expected to be reported during 2014 [2].


A film-coated gastric-resistant tablet aimed at reducing gastrointestinal adverse events (e.g. diarrhoea and nausea) associated with other formulations [1].


Nov 12: NCT01726933 is a multi-centre, randomized, double-blind, three-arm, 16 week, adaptive PIII study to investigating LAS41008 vs LASW1835 vs placebo in 690 patients with moderate to severe chronic plaque psoriasis. Both LAS41008 and LASW1835 are gastric resistant tablets and are given in doses of up to 6 tablets a day. The co-primary outcomes are changes from baseline to week 16 in PASI 75 and Physician Global Assessment (PGA). The study starts Nov 12 and is due to complete Dec 14 [1].

Evidence based evaluations