|
 (Reuters) - 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.
[to top of second column] |
"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.
(Reporting by Ransdell Pierson; Editing by Alan Crosby)
[© 2016 Thomson Reuters. All rights
reserved.] Copyright 2016 Reuters. All rights reserved. This material may not be published,
broadcast, rewritten or redistributed.
 |
