The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for the regulatory approval of a new oral formulation of dimethyl fumarate (DMF).
Named Skilarence and produced by Almirall, the global pharmaceutical company based in Barcelona, the product has approval in all EU member states as a first-line induction and long-term treatment for adults with moderate-to-severe chronic plaque psoriasis.
“This will provide European patients and healthcare professionals with a new therapeutic alternative in the systemic treatment of this chronic dermatological disease,” said Eduardo Sanchiz, Almirall's CEO. “This is a new milestone to improving lives of psoriasis patients.”
In trial
In September 2016, Almirall presented positive results from the randomised, double-blind, placebo-controlled Phase III trial (BRIDGE) showing the efficacy and safety of dimethyl fumarate compared to Fumaderm.
These results, including co-primary and secondary endpoints, were accepted for publication in the British Journal of Dermatology.
“From now on, patients in Germany and in the rest of the European Union will have a new alternative for treating their psoriasis. We are proud to extend the access of this fumaric acid derivative to the rest of the European Union,” said Xavier Llaurado, Almirall's Regulatory Affairs Director.
