Weekly Top News – Psoriasis – June 22, 2020

June 22, 2020

Stelara (ustekinumab) / J&J; Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
A Study of Subcutaneous Risankizumab Injection for Pediatric Participants With Moderate to Severe Plaque Psoriasis to Assess Change in Disease Symptoms (clinicaltrials.gov) – Jun 17, 2020 – P3; N=132; Not yet recruiting; Sponsor: AbbVie


Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
AOTMiT: What will the Transparency Council do in July? [Google translation] (medexpress.pl) – Jun 17, 2020 – “AOTMiT published the Transparency Council’s work plan from July 1 to July 31….MEETING OF THE TRANSPARENCY COUNCIL NO. 28/2020 13 JULY 2020: Ilumetri (tildrakizumab) – CONDITIONAL Indication: as part of the drug program ‘Treatment of moderate to severe plaque psoriasis’; 30/2020 27 JULY 2020: Dupixent (dupilumabum) – CONDITIONAL Indication: as part of the drug program : ‘Treatment of severe form of atopic dermatitis (ICD-10 L20)’ Decision problem: preparation of a position on drug evaluation…”


Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
Sun Pharma and Hikma enter into unique licensing settlement for Ilumya for Middle East & North Africa areas (Equitybulls) – Jun 15, 2020 – “Sun Pharmaceutical…announced that one of its wholly-owned subsidiaries and Hikma Pharmaceuticals PLC (Hikma) have entered into an exclusive licensing and distribution agreement for Ilumya…for the Middle East & North Africa (MENA) region….Hikma will be responsible for the registration and commercialization of the product in all MENA markets and Sun Pharma will be responsible for product supply…The term of this agreement is 15 years from first sale, with two years’ automatic renewal periods.”


Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Study to Assess the Safety and Change in Disease Symptoms of Risankizumab (Skyrizi Prefilled Syringe for Injection) in Adult Participants With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) – Jun 16, 2020 – P; N=3000; Not yet recruiting; Sponsor: AbbVie


Tremfya (guselkumab) / J&J
GULLIVER: A Study of Guselkumab in Naive or Bio-experienced Participants With Regional (Facial and Genital) Psoriasis (clinicaltrials.gov) – Jun 19, 2020 – P; N=400; Recruiting; Sponsor: Janssen-Cilag S.p.A.


Tremfya (guselkumab) / J&J
New phase 3 data for Tremfya (guselkumab), a first-in-class IL-23 p19 subunit iInhibitor, show consistent, high levels of skin clearance through four years in adult patients with moderate to severe plaque psoriasis (Businesswire) – Jun 15, 2020 – P3, N=992; VOYAGE 2 (NCT02207244); P3, N=837; VOYAGE 1 (NCT02207231); Sponsor: Janssen Research & Development, LLC; “The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new long-term plaque psoriasis data for Tremfya® (guselkumab), a first-in-class treatment showing consistent, high levels of skin clearance at week 100 and week 204 (four years)…In the open-label extension of VOYAGE 2, at four years, 80 percent of patients who were treated with guselkumab 100 mg every 8 weeks (q8w), achieved at least 90 percent improvement in the Psoriasis Area and Severity Index (PASI 90) score….These data are being shared online as an accepted poster (P15300) by the American Academy of Dermatology….Separately, data…VOYAGE 1 trial…are also being shared online as a poster (P15287)…at week 48, approximately 42 percent of guselkumab-treated patients and 23 percent of adalimumab-treated patients were symptom-free.”


bimekizumab (UCB4940) / UCB
BE BRIGHT: A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis (clinicaltrials.gov) – Jun 19, 2020 – P3; N=1355; Active, not recruiting; Sponsor: UCB Biopharma S.P.R.L.; Recruiting –> Active, not recruiting

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