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Takeda has reported the 2 P-III (Latitude PsO 3001 & PsO 3002) trial results assessing zasocitinib (QD, PO) in 693 & 1108 adults, respectively, with mod. to sev. PsO, where both studies showed improved NAPSI scores vs PBO at 16wks.
Trials also showed that 77% (3001) & 74% (3002) pts reached ssPGA 0/1 response…
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The US FDA has approved Lipfendra (20mg, PO) as an adjunct to lifestyle intervention to reduce LDL-C in adults with hypercholesterolemia, incl. HeFH, based on 2 P-III trials (CORALreef Lipids & CORALreef HeFH) assessing it vs PBO
At Wk. 24 in Lipids trial, Lipfendra reduced LDL-C by 57% vs a 3% increase from…
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Junshi Biosciences has entered into a license agreement with Fosun Wanbang Pharma Group for roconkibart in the Greater China region, incl. Mainland China, Hong Kong SAR, Macao SAR, & Taiwan
Companies will cooperate on the development, registration, manufacturing & commercialization of roconkibart, an anti-IL-17A mAb, which showed 91% reached PASI 90 at wk. 16…
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The Chinese NMPA has approved Akeso’s gumokimab (AK111; SC, 17 doses per year, incl. loading) to treat mod. to sev. plaque psoriasis in adults based on the P-III (AK111-301) trial & 3 supportive studies, showing rapid improvement in 2wks.
Data showed short-term efficacy, with a PASI 75 response rate approaching 94.6% & PASI 100 reaching…
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Takeda has reported topline P-III (LATITUDE Atlas) trial data assessing zasocitinib (TAK-279; 30mg, PO, QD) vs deucravacitinib (6mg, QD) in 606 adults with mod. to sev. PsO
Trial showed that zasocitinib was superior to deucravacitinib in the 1EP, with improved PASI 100 response rates at Wk. 16, plus in all key 2EPs, incl. PASI 90…
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Samsung Bioepis has reported the launch of Ustekinumab BS 45 mg Syringe for SC Injection 「NIPRO」, a biosimilar version of Stelara, in Japan, marking the company’s first commercialized product in the country
The biosimilar will be commercialized by NIPRO CORPORATION under a strategic partnership between Samsung Bioepis & NIPRO in 2025, focused on developing &…
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The NMPA has approved Enstilar (calcipotriene/betamethasone dipropionate) for the treatment of adult patients with plaque psoriasis in China. Following NMPA approval, Enstilar is planned to launch in China later this year
NMPA approval was backed by a P-III trial (n=604) in Chinese adults with plaque psoriasis, where QD Enstilar showed superior efficacy and met…
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The 2 P-III (Latitude PsO 3001 & PsO 3002) trials assessed zasocitinib in 693 & 1108 adults with mod. to sev. PsO, with plans for NDA submission to FDA & other authorities starting Takeda’s FY’26
PsO 3001 showed 71.4% achieved sPGA 0/1 vs PBO (10.7%) & apremilast (32.1%), with 39.9% reaching sPGA…
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Eli Lilly has reported P-IIIb (TOGETHER-PsO) trial data assessing Taltz (ixekizumab) + Zepbound (tirzepatide) vs Taltz alone in 274 adults with mod. to sev. plaque psoriasis & obesity/overweight with ≥1 additional weight-related comorbid condition
At 36wks., the trial met its 1EP with 27.1% pts reaching PASI 100 & ≥10% weight loss compared to 5.8% pts. Trial…
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Eli Lilly has reported P-IIIb (TOGETHER-PsA) trial assessing concomitant Taltz (ixekizumab) & Zepbound (tirzepatide) vs Taltz alone in 271 adults with active PsA & obesity or overweight with ≥1 weight-related condition
Trial met its 1EP, with 31.7% of pts achieving ACR50 & ≥10% weight loss at Wk. 36 vs 0.8%, & met a key…

