Patients with severe atopic dermatitis in the U.K. will have access to Sanofi and Regeneron's investigational drug dupilumab through the Early Access to Medicines Scheme (EAMS) before full marketing authorization has been granted. The go-ahead to clear dupilumab through EAMS, by the Medicines and Healthcare Products Regulatory Agency (MHRA), means that the interleukin (IL)-4/IL-13–targeting monoclonal antibody will be available to adult patients in the U.K. who have severe atopic dermatitis and have failed to respond to all currently approved therapies, or who are intolerant to or not suitable for approved treatments. The formal application for marketing approval of dupilumab in Europe is currently under review by the European Medicines Agency (EMA).
Sanofi points out that drugs included under EAMS are intended to address seriously debilitating or life-threatening conditions for which there are no adequate treatment options. Drugs approved under the scheme have been primarily for life-limiting diseases, including cancer. “People dismiss atopic dermatitis as 'just a skin condition', but it is much more than that,” stated Michael Cork, Ph.D., consultant dermatologist, professor of dermatology, and head of Sheffield Dermatology Research, University of Sheffield. “Atopic dermatitis is a chronic, systemic, inflammatory disease that can have an immense impact on sufferers' lives. Up until now, doctors have had little to offer even the most severe patients beyond an escalating routine of topical treatments and immunosuppressants. Dupilumab targets an underlying cause of the condition and gives us a new treatment approach for patients with the most clinical need.”
“Sanofi is committed to ensuring that people who really need dupilumab have access to it as soon as possible—which is why we applied for EAMS,” added Dr. Jasmin Hussein, head of Atopic Dermatitis and Asthma, Sanofi Genzyme UK & Ireland. “MHRA recognizing the innovation that dupilumab represents for people living with atopic dermatitis is a significant step forward.”
Dupilumab has been developed through Sanofi and Regeneron’s antibody collaboration, originally established in 2007. If approved, dupilumab will be commercialized by Regeneron and Sanofi Genzyme.
Earlier this month, the two firms reported new data from the pivotal Phase III CHRONOS study evaluating dupilumab in combination with topical steroids in patients with moderate-to-severe atopic dermatitis. In September 2016, the FDA accepted for priority review the Biologics License Application for dupilumab as a treatment for adult patients with inadequately controlled moderate-to-severe atopic dermatitis. The Prescription Drug User Fee Act (PDUFA) target date is March 29th, 2017.