Delgocitinib Cream Significantly Improves Chronic Hand Eczema in Trial
The trial met its primary endpoint with a significantly larger proportion of delgocitnib-treated patients achieving treatment success.
The trial met its primary endpoint with a significantly larger proportion of delgocitnib-treated patients achieving treatment success.
The approval was based on data from the phase 3 PRIME and PRIME2 trials.
Roflumilast is a highly potent and selective phosphodiesterase type 4 inhibitor.
The sBLA is supported by data from the phase 3 PRIME2 and PRIME trials that assessed dupilumab in patients 18 years of age and older with prurigo nodularis.
In a previous US phase 2 trial, no clear dose response was observed with difelikefalin.
The phase 3 PRIME study evaluated dupilumab in 151 adults with inadequately controlled prurigo nodularis.
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The randomized, double-blind, placebo-controlled, parallel-group PRIME2 study included 160 patients with prurigo nodularis.
The approval was based on data from the pivotal phase 3 KALM-1 and KALM-2 trials, as well as data from an additional 32 clinical studies.