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Incyte announced today that the FDA has accepted a new drug application (NDA) for ruxolitinib cream and will give it priority review.
reed cocotinib cream is a topical drug-specific selective JAK1/JAK2 inhibitor used to treat adiotic dermatitis (AD), a type of eczema.
special dermatitis is a serious chronic, relapsed skin disease.
symptoms are itching, dry skin and inflammation, which can occur anywhere in the body.
severe mild dermatitis is severe itching, resulting in visible damage to the skin.
like other chronic inflammatory diseases, adesthetic dermatitis is mediated by the immune system and is associated with complex interactions between immune cells and inflammatory cytokines.
reed cocotinib cream is a proprietary external formula for JAK1/JAK2 selective inhibitor reed cocotinib.
JAKs belong to the cytoplasm tyrosine kinase family and function as a transductive cytokine (e.g. interferon)-mediated signal.
can regulate the activity of inflammatory factors associated with the pathology of adiopathic dermatitis and may directly regulate itching.
application is based on a clinical development project called TRuE-AD, which includes two randomized double-blind, phase 3 clinical trials with an endoentic control. The main endpoint of the
trial was the proportion of subjects who achieved the researcher's overall assessment of treatment success (IGA-TS), defined as 0 (skin symptoms completely cleared) or 1 (skin symptoms almost completely cleared) and at least 2 points better than the baseline at week 8 of treatment.
trial results showed that in two Phase 3 clinical trials, patients treated with different doses of reed cocotinite cream were significantly better than the control group in the proportion of patients who reached IGA-TS after 8 weeks of treatment.
company used a priority review voucher to submit the NDA, reducing the review period by four months, and the FDA expects to respond by June 21.
: This article is intended to introduce medical and health research, not treatment options recommended.
if you need guidance on treatment options, visit a regular hospital.
resources: sicyte Announces Acceptance and Priority Review of NDA for Ruxolitinib Cream for Atopic Dermatitis. Retrieved February 19, 2021, from Ruxolitinib Cream: Phase 3 Data in Atopic Dermatitis. Retrieved February 19, 2021, from