Breakthrough eczema drug given FDA approval
pharmafile | March 29, 2017 | News story | Research and Development, Sales and Marketing |Â Â Dupixent, Regeneron, SanofiÂ
Regeneron and Sanofi have received approval for its eczema treatment, Dupixent, by the FDA. The treatment will be the first biologic medicine approved for the treatment of adults with moderate-to-severe atopic dermatitis. Unusually, for such a ground-breaking therapy, the drug is priced at an expensive but not prohibitive list price of $37,000.
Both companies had involved insurers in price negotiations early into the process and though the price of the drug is undoubtedly expensive, there was room to push the price even further. It would not have been an unusual step; the drug comes as a first, it displays significant efficacy in sufferers and it could point to psoriasis treatments that charge $50,000 as a comparative medicine. It’s a step that already has many in the industry talking, not least because it will neither please investors nor insurers.
With no rivals, the treatment will be able to establish itself in the market quickly. Analysts have pointed to $3 to $4 billion potential annual sales of the drug. The drug received a breakthrough therapy designation by the FDA, which speeds up the process from application to approval, based on evidence.
Dupixent displayed impressive results showing that, on average, 37% of patients using the drug as a stand-alone treatment for their eczema displayed clear or almost clear skin after 16 weeks of treatment.
“Dupixent is the result of years of tireless research by our scientists into the underlying causes of allergic and atopic diseases. In atopic dermatitis, Dupixent was shown to help clear the skin and manage the intense itch caused by the disease,” said George D. Yancopoulos, M.D., Ph.D., Founding Scientist, President, and Chief Scientific Officer, Regeneron. “Today’s approval would not be possible without the dedication of the clinical investigators and the participation of the patients who took part in the global LIBERTY AD clinical program.”
Now it has received FDA approval, the next stage for the drug will be to achieve approvals in other indications. It is already being studied in children and adolescents, whilst there are Phase 3 trials underway in the treatment of asthma.
Ben Hargreaves
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