Weekly Top News – Psoriasis – April 9, 2019

April 9, 2019

Idacio (adalimumab biosimilar) / Fresenius Kabi
Fresenius Kabi receives European Commission approval for adalimumab biosimilar Idacio (Fresenius Kabi Press Release) – Apr 3, 2019 – “Fresenius Kabi…announced today that the European Commission (EC) granted marketing authorization for IDACIO®, an adalimumab biosimilar, for all indications of the reference medicine.”
European regulatory

 

bimekizumab (UCB4940) / UCB
Bimekizumab clinical trial estimate: Data from P3 BE SURE trial (NCT03412747) for psoriasis in H1 2019 (Infinata) – Apr 1, 2019 – A subscription to Thomson ONE is required to gain full access to report 66478978; Page no: 2; REPORT TITLE: “UCB S.A. – Company report”; AUTHOR: Infinata, et al; DATE: 03/05/2019
P3 data

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
Efficacy and Safety of Tildrakizumab in the Treatment of Scalp Psoriasi (clinicaltrials.gov) – Apr 1, 2019 – P3; N=136; Not yet recruiting; Sponsor: Sun Pharma Global FZE
Clinical • New P3 trial

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Risankizumab regulatory estimate: PDUFA date for psoriasis on April 26, 2019 (William Blair) – Apr 1, 2019 – A subscription to Thomson ONE is required to gain full access to report 67011697; Page no: 5; REPORT TITLE: “William Blair Biopharma Catalyst watch second quarter 2019”; AUTHOR: Xu, Yu Katherine, et al; DATE: 03/29/2019
PDUFA date

 

bimekizumab (UCB4940) / UCB
BE COMPLETE: A Study to Evaluate the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis (clinicaltrials.gov) – Apr 1, 2019 – P3; N=390; Not yet recruiting; Sponsor: UCB Biopharma S.P.R.L.
Clinical • New P3 trial

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
Efficacy and Safety Study of Tildrakizumab in the Treatment of Nail Psoriasis (clinicaltrials.gov) – Apr 1, 2019 – P3; N=146; Not yet recruiting; Sponsor: Sun Pharma Global FZE
Clinical • New P3 trial

 

Cosentyx (secukinumab) / Novartis
Novartis first-in-class Cosentyx approved in China for psoriasis patients (Novartis Press Release) – Apr 2, 2019 – “Novartis…announced today that the China Health Authority NMPA approved Cosentyx® (secukinumab), the first-in-class interleukin-17A (IL-17A) inhibitor for moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy…Positive China data presented recently makes us hopeful for the clinical use of secukinumab in China.”
Non-US regulatory

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