Sanofi’s dupilumab receives EAMS positive scientific opinion from UK MHRA for AD
UK's Medicines and Healthcare Products Regulatory Agency (MHRA) has granted French pharmaceutical company Sanofi a positive scientific opinion for the use of dupilumab to treat patients with atopic dermatitis (AD).
MHRA’s positive scientific opinion has been granted to Sanofi’s investigational dermatology treatment through the Early Access to Medicines Scheme (EAMS).
Sanofi Genzyme UK and Ireland AD and Asthma head Dr Jasmin Hussein said: “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.
“MHRA recognising the innovation that dupilumab represents for people living with atopic dermatitis is a significant step forward.”
Under EAMS, the eligible adults suffering from severe AD in the UK can have access to dupilumab before the drug is granted marketing authorisation in the country.
Dupilumab can be used on adult patients with AD that has failed to respond to other currently approved therapies, and also on people suffering from severe AD who are intolerant of, or ineligible for, all approved treatments.
University of Sheffield dermatology research head and dermatology professor Michael Cork said: “People dismiss atopic dermatitis as 'just a skin condition', but it is much more than that.
“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.”
Dupilumab is an investigational fully human monoclonal antibody, which is currently under joint development with US-based biotechnology company Regeneron and Sanofi and its safety and efficacy have not been fully evaluated by any regulatory body.
The formal EU regulatory application for dupilumab is currently under review by the European Medicines Agency (EMA).
If approved, the drug will be commercialised by Regeneron and Sanofi Genzyme, the specialty care global business unit of Sanofi.
Image: Atopy of the flexure crease of the elbow. Photo: courtesy of James Heilman, MD.