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395435009

New Medicines

Wynzora Mild to moderate psoriasis, including scalp, in adults

Information

Wynzora
New formulation
Almirall
EPI Healthcare

Development and Regulatory status

Launched
Approved (Licensed)
Approved (Licensed)
December 2021
Dec 21Wynzora cream available in the UK. Price for 60g=£35.66 [7].
Sep 21Licensed in the EU via the decentralised procedure [6].
Jul 21Approved by MHRA for the topical treatment of mild to moderate psoriasis vulgaris, including scalp psoriasis, in adults [5].
Mar 21Now listed in Almirall pipeline [4].
Aug 20MC2 Therapeutics and EPI Health enter into marketing agreement for Wynzora in the US. MC2 Therapeutics plans to launch in the US in Q1 2021 [3].
Jul 20FDA approves Wynzora (betamethasone dipropionate/calcipotriol cream, w/w 0.005%/0.064%) for once-daily topical treatment of plaque psoriasis in adults 18 years of age or older [3].
Jun 20Filed in the EU using the decentralised procedure [2].
Sep 19Filed in the US [3].

Category

A synthetic vitamin D3 analogue and a synthetic corticosteroid. Applied once daily. Uses PAD™ technology, which uniquely enables stability of both calcipotriol and betamethasone dipropionate in a convenient-to-use aqueous formulation.
The prevalence of psoriasis is estimated to be about 1.3-2.2% in the UK, with the highest prevalence being in white people. Men and women are equally affected. It can occur at any age but the majority of cases first present before the age of 35 years. It is uncommon in children. Plaque psoriasis accounts for 90% of all people with psoriasis [1].
Mild to moderate psoriasis, including scalp, in adults
Topical

Trial or other data

Jun 20PIII study (MC2-01-C2; NCT03308799) also met its primary outcome. In the US-based study (n=796), Wynzora was superior to Taclonex at week 8 based on treatment success defined as a minimum two-point decrease in the PGA score (40.1% vs. 24.0%, p<0.0001). Accordingly, the trial met its primary endpoint to demonstrate non-inferiority to Taclonex. For secondary endpoints, Wynzora was superior to Taclonex based on percentage reduction in mPASI from baseline to Week 8 (64.8% vs. 52.3%, p<0.0001) [3].
Dec 19MC2 Therapeutics announces PIII trial (MC2-01-C7; NCT03802344) met its primary outcome. Wynzora Cream has statistically significantly greater treatment efficacy compared to Daivobet Gel. PGA treatment success defined as a minimum two-point decrease in the Physician Global Assessment (PGA) score to clear or almost clear disease at Week 8 (p<0.05). The PGA treatment success for Wynzora™ Cream was 52%. Change from Baseline in mPASI to Week 8 (p<0.05, per protocol analysis set). The change from Baseline in mPASI was 68% for Wynzora Cream and statistically significantly better than Daivobet Gel already at Week 4 (p<0.001). Wynzora Cream has statistically significantly better patient reported outcomes compared to Daivobet Gel. Patient reported treatment convenience (PTCS) at Week 4 (p<0.001) and Week 8 (p<0.0001). Change from Baseline in the dermatology life quality index (DLQI) at Week 4 (p<0.05) and Week 8 (p<0.05). Wynzora Cream demonstrates a favorable safety profile with few drug-related adverse reactions generally of mild severity. No drug-related adverse reactions with a frequency =1% in the safety data base proposed for labelling in US and EU [3].
Sep 18A large number of studies have been conducted including three PII and two PIII. Four-week PII (MC2-01-C1) study (n=33) started in Jan 14 in Western Europe and investigated the efficacy of MC2-01 (calcipotriol + BDP) compared to MC2-01 (calcipotriol) and MC2-01 vehicle control in the treatment of stable plaque psoriasis assessed by Total Clinical Score (TCS). Four-week PII (MC2-16-C1) study (n=24) started in Dec 15 in Western Europe and also investigated the efficacy of calcipotriol + BDP vs. calcipotriol and vehicle control in the treatment of stable plaque psoriasis assessed by TCS. PII (MC2-01-C3) study recruited in the US - MC2-01 cream and Taclonex ointment were compared in subjects with clinically diagnosed extensive psoriasis vulgaris; treatment period was 8 weeks for the MC2-01 group and 4 weeks for the Taclonex group. Eight-week PIII study (MC2-01-C2; NCT03308799) began in Jun 17 in North America and aimed to show therapeutic non-inferiority of MC2 01 cream to active comparator (Taclonex), as well as to characterise the safety profile of MC2 01 cream in subjects with psoriasis vulgaris. Eight-week PIII study (MC2-01-C7; NCT03802344) began in Aug 18 and recruited patients in Eastern and Western Europe; it evaluated the efficacy and safety of MC2-01 vs. Daivobet and vehicle control. [2,3].