Dimethyl fumarate
Published 19th January 2016, updated 3rd October 2017
Articles
Safety in Lactation: Other immunomodulating drugs
Several drugs in this section (dimethyl fumerate, interferon beta, fingolimod, glatiramer, natalizumab) are used in multiple sclerosis (MS) but are not normally interchangeable as they… Aldesleukin Bacillus Calmette-Guerin Canakinumab Dimethyl fumarate Fingolimod Glatiramer Histamine Interferon alfa Interferon beta Interferon gamma Lenalidomide Mifamurtide Natalizumab Peginterferon alfa-2a ThalidomideMedicine Compliance Aid Stability
Tecfidera · Biogen
Lactation Safety Information
New Medicines
Skilarence · Chronic plaque psoriasis, moderate-to-severe
Information
Development and Regulatory status
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].
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Further information
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].
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