Patients in UK to be given early access to Sanofi’s eczema treatment
pharmafile | March 14, 2017 | News story | Research and Development, Sales and Marketing | Dupilumab, MHRA, Sanofi
Sanofi’s treatment for atopic dermatitis, otherwise known as eczema, has been given a positive scientific opinion through the MHRA’s Early Access to Medicines Scheme (EAMS). This means that the treatment for eczema, called dupilumab, will be made available to patients before it is officially given marketing authorisation.
The treatment is an investigational fully human monoclonal antibody. It works by inhibiting the signalling of two cytokines, IL-4 and IL-13, required in immune response and is thought to lead to the inflammation reaction typical of eczema.
The drug has had particularly impressive results in trials, with recent results presented at the American Academy of Dermatology revealing that 36-40% of patients taking dupilumab alongside topical steroids had clear or almost clear skin, against 12.5% of those only taking topic steroids with a placebo. The study found that the mean improvement in symptoms had improved by 78-80% on the baseline compared with 46% of those taking a placebo. The results were gathered over the course of a year.
“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,” said Dr Jasmin Hussein, Head of Atopic Dermatitis and Asthma, Sanofi Genzyme UK & Ireland.
The drug is expected to receive a decision from FDA later this month and is also under review by the EMA. Sanofi expect the drug to become its latest blockbuster, with some predictions expecting sales to reach $2.8 billion a year at its peak.
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