Regeneron, Sanofi eczema drug clears hurdles in big trials
APRIL 1 | BY RANSDELL PIERSON
Regeneron Pharmaceuticals Inc and Sanofi said on Friday their experimental treatment for eczema proved highly effective in two large studies, without serious side effects often seen with standard treatments for the chronic inflammatory skin disease.
The drugmakers said they would seek U.S. approval this year for their injectable drug, dupilumab, based upon strong results in the trials involving almost 1,400 adults with moderate to severe disease.
If cleared by regulators, it would be the first approved systemic treatment for the condition, which in severe cases produces infection-prone rashes over much of the body and a constant itch as bad as poison ivy.
Some analysts expect dupilumab to cost up to $30,000 a year and to capture eventual annual sales of more than $5 billion.
In the two identical Phase 3 studies, respectively, there was a clearing or near clearing of skin lesions among 37 percent and 36 percent of patients who received dupilumab weekly and 38 percent and 36 percent who received injections every two weeks.
An average of roughly 70 percent improvement in rash area and eczema severity was seen among patients taking the drug in both trials, about twice the improvement seen among those receiving placebo.
The rate of serious side effects, including infections, was less for dupilumab than for placebos.
Dupilumab works by blocking IL-4 and IL-13, proteins Regeneron believe to be underlying causes not only of eczema, but of other allergic conditions like asthma and nasal polyps for which the drug has shown favorable results in smaller Regeneron studies.
"If you look across our research programs, these two proteins appear to be key drivers of allergic responses in all these diseases," George Yancopoulos, Regeneron's research chief, said in an interview.
Eczema, also called atopic dermatitis, affects an estimated 2 percent of U.S. adults, and as many as 10 percent to 20 percent of children - the majority of cases being of mild to moderate severity.
Regeneron is best known for its blockbuster Eylea treatment for macular degeneration, a leading cause of blindness, and recently won approval for a new type of cholesterol fighter.
Current treatments for eczema include cyclosporine, an oral immune suppressant that is not approved for the condition and raises risks of infection and kidney problems. Topical steroid ointments are the mainstay of treatment, but also provide limited long-term relief and can cause worrisome side effects. |
