The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) today recommended granting marketing authorization for dimethyl fumarate (DMF; Skilarence, Almirall, SA) for the treatment of psoriasis.
"Thanks to its efficacy and safety profile, this new oral formulation will allow us to bring a new therapeutic alternative that covers unmet needs in the systemic treatment of moderate-to-severe psoriasis to many patients in Europe", Alfredo Barón de Juan, Almirall's executive vice president, global commercial operations, explained in a news release. "We are convinced that DMF will provide an important addition to the available therapeutic arsenal in the treatment of this disease."
Dimethyl fumarate is a fumaric acid ester recommended as an oral first-line treatment for adults with moderate-to-severe chronic plaque psoriasis.
Its anti-inflammatory and immunomodulating effects are thought to be "mainly mediated by an interaction with intracellular reduced glutathione, which helps to regulate the altered transcriptional activity of the nuclear factor kappa-light-chain-enhancer of activated B-cells," the EMA explained in a news release.
Skilarence will be sold as 30-mg and 120-mg gastro-resistant tablets. It is proposed that dimethyl fumarate be prescribed by physicians experienced in psoriasis treatment.
The recommendation follows consideration of results from the randomized, double-blind, placebo-controlled phase 3 trial (BRIDGE), which demonstrated the efficacy, safety, and noninferiority of Skilarence compared with Fumaderm (Fumapharm AG).
The most frequently seen adverse effects are gastrointestinal events, flushing, and lymphopenia.
The summary of product characteristics will provide detailed recommendations for the use of this product; it will be published in the European public assessment report and distributed in all official European Union languages after the European Commission grants marketing authorization.