ANZUPGO

The pharmacokinetics of ANZUPGO were evaluated in a pharmacokinetic (PK) trial involving 15 adult subjects 22 to 69 years of age with moderate to severe CHE and in 313 subjects in TRIAL 2 [see Clinical Studies (14) ].

AbsorptionIn the PK trial, subjects applied on average 0.87 g of ANZUPGO topically to the affected areas of the hands and wrists twice a day for 8 days. The mean ± SD maximum plasma concentration (C max ) and area under the concentration-curve from time 0 to 12 hours (AUC 0-12 ) o...

The efficacy of ANZUPGO was evaluated in two randomized, double-blind, vehicle-controlled, 16-week trials (TRIAL 1 [NCT04871711] and TRIAL 2 [NCT04872101]) which enrolled a total of 960 adult subjects with moderate to severe CHE who had a history of inadequate response to, or for whom topical corticosteroids were not advisable. All subjects who completed TRIAL 1 and TRIAL 2 were eligible to enroll into a long-term extension trial (TRIAL 3 [NCT04949841]). Disease severity of enrolled subjects was defined using the Investigator's Global Assessment for chronic hand eczema (IGA-CHE) score and the ...

Adverse reactions that were reported in ≤ 1% of subjects were application site pain, paresthesia, pruritus, erythema, and bacterial skin infections including finger cellulitis, paronychia, other skin infections, leukopenia, and neutropenia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact LEO Pharma Inc. at 1-877-494-4536 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction r...

None None. ( 4 )

Serious Infections: ANZUPGO may increase the risk of infection. Eczema herpeticum was observed in a subject treated topically with ANZUPGO. Avoid use of ANZUPGO in patients with an active or serious infection. If a serious infection develops, discontinue ANZUPGO until the infection resolves. ( 5.1 ) Non-melanoma Skin Cancers: Non-melanoma skin cancers including basal cell carcinoma have been reported in subjects treated with ANZUPGO. Periodic skin examinations are recommended for all patients, p...