Regeneron and Sanofi Monopoly on Atopic Dermatitis Market May Soon End
With nearly 10 million children and 16.5 million adults suffering from atopic dermatitis, the most common form of eczema driven by allergic reactions, the market for effective treatments is nothing to sneeze at.
Regeneron and Sanofi broke ground with the 2017 approval of the first biologic drug for the condition. Dupilumab, marketed as Dupixent, is an under-the-skin injectable monoclonal antibody that blocks the receptor for interleukin-4 and 13.
First approved for moderate-to-severe atopic dermatitisin adults, the drug quickly racked up approvals extending to kids six years old and older as well as other indications: certain asthma patients 12 and up and chronic rhinosinusitis with nasal polyposis for adults as well.
The partners haven’t stopped there. Today, Regeneron and Sanofi announced Dupixent met all primary and secondary endpoints in its atopic dermatitis trial in children as young as six months of age. After the first dose, the itch rapidly improved in one week, with skin clearance in two weeks.
The injection proved to clear or almost clear the skin of seven times more patients than topical corticosteroids, the standard-of-care treatment, alone by week 16. Overall disease severity dropped by 70% and itchiness by 49% for those using Dupixent in addition to topical corticosteroids. Having this effective option available for babies and young children is a big step.
“Currently, the standard of care for this patient population is topical steroids and other immunosuppressive medicines may be used which can damage delicate skin and, if used long-term, potentially impact growth,” said John Reed, global head of Research and Development at Sanofi.
“Knowing that safety is of the utmost importance for physicians and parents when considering treatment options for children and infants, we are encouraged by the results of this trial showing Dupixent addressed the signs and symptoms of atopic dermatitis without broadly suppressing the immune system, demonstrating the potential it could have for these very young patients.”
Researchers in the drug’s development believe it could also address the underlying type 2 inflammation that contributes to other allergy-related diseases later in life, like asthma. Pivotal data from a Phase III trial in kids ages 6–11 announced in May showed Dupixent significantly reduced asthma attacks and improved lung function in children. Topline results released in July showed the drug is also showing significant improvements for reducing hives and itchiness for patients with moderate-to-severe chronic spontaneous urticaria.
Dupixent is expensive. The recommended dosing for adults is two 300mg injections to start, followed by one injection every other week. The average cash price for two syringes of that dose is over $3200. Like many pharmaceutical companies have done for their high list price medications, Dupixent has a copay card available to significantly lower the price for commercially insured patients.
While Regeneron and Sanofi have enjoyed their little corner on the atopic dermatitis market for over four years now, traffic is starting to heat up. Pfizer is boasting its own Phase III results in a head-to-head study comparing its once-daily oral tablet abrocitinib to subcutaneous injection Dupixent.
Abrocitinib was “statistically superior” to Dupixent in achieving a 4-point improvement in the severity of symptoms. Both drugs did have patients experience adverse events, with a larger percentage in the abrocitinib arm. Results of the trial will be shared with the FDA “at the appropriate time.”
For fewer side effects, patients may end up turning toward Leo Pharma’s Adtralza (tralokinumab). The drug has already been approved for moderate-to-severe atopic dermatitis in Europe but is still awaiting U.S. approval.
Eli Lilly has also found success in the AD market. Top-line results from its Phase III were released just two weeks ago, touting that more than half of the participants who had moderate-to-severe AD experienced at least 75% clearance after consistently taking lebrikizumab.
Full study results won’t be out until next year. Five key trials are currently ongoing.