The UK’s MHRA has selected Sanofi’s dupilumab for its early access to medicines scheme, which lets British patients use it before marketing authorization.
After two successful Phase III trials, Sanofi’s treatment for atopic dermatitis, dupilumab, is under review for market approval by the EMA. But patients in the UK will be able to access the therapy before a decision is made. Dupilumab will now be available in the UK for adults with severe atopic dermatitis that have not responded or are not eligible for all approved treatments.
The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) started the Early Access to Medicines Scheme (EAMS) in 2015 with the aim of helping patients suffering from severely debilitating or life-threatening conditions with no adequate treatment options.
For Sanofi, this decision is proof of the potential of its antibody and could help the company gain recognition over competitors like Leo Pharma, which is developing its own antibody against atopic dermatitis, tralokinumab.
The decision to include dupilumab in the program also reflects how debilitating atopic dermatitis can be. Also known as eczema, this chronic inflammatory disease not only affects patients physically but also psychologically.
“Up until now, doctors have had little to offer even the most severe patients beyond an escalating routine of topical treatments and immunosuppressants,” said Michael Cork, a consultant dermatologist at the University of Sheffield. “Dupilumab targets an underlying cause of the condition and gives us a new treatment approach for patients with the most clinical need.“
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