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Weekly Top News – Psoriasis – October 14, 2019

October 14, 2019

Stelara (ustekinumab) / J&J
Janssen submits application to U.S. FDA seeking approval of Stelara (ustekinumab) for the treatment of pediatric patients with moderate to severe plaque psoriasis (PRNewswire) – Oct 7, 2019 – “The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking expanded approval of STELARA® (ustekinumab) to treat pediatric (ages 6-11) patients with moderate to severe plaque psoriasis (PsO)….The STELARA sBLA is based on results from the Phase 3 CADMUS Jr study…”

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
Sun Pharma presents long-term study results that show significant skin clearance with Ilumya (tildrakizumab-asmn) maintained over four years in people with moderate-to-severe plaque psoriasis (PRNewswire) – Oct 9, 2019 – P3, N=772; reSURFACE 1 (NCT01722331); Sponsor: Sun Pharma; P3, N=1,090; reSURFACE 2 (NCT01729754); Sponsor: Sun Pharma; “Sun Pharmaceutical Industries…today announced that one of its wholly owned subsidiaries presented long-term follow-up data from ILUMYA

® (tildrakizumab-asmn) Phase 3 reSURFACE 1 and 2 trials at the 28th European Academy of Dermatology and Venereology Congress (EADV) in Madrid, Spain.”

Taltz (ixekizumab) / Eli Lilly
Lilly presents positive results for Taltz (ixekizumab) in pediatric patients with moderate to severe plaque psoriasis at the 28th Annual European Academy of Dermatology and Venereology (EADV) Congress (Eli Lilly Press Release) – Oct 12, 2019 – P3, N=201; Ixora-peds (NCT03073200); Sponsor: Eli Lilly and Company; “Eli Lilly and Company…announced today that Taltz met co-primary endpoints as well as all major secondary endpoints in a Phase 3 study in pediatric patients with moderate to severe plaque psoriasis, demonstrating that 89 percent of patients treated with Taltz achieved a significant 75 percent improvement from baseline to Week 12 on their Psoriasis Area…Results of the study are being presented as a late-breaking oral presentation at the European Academy of Dermatology and Venereology Congress (EADV) in Madrid, Spain….Based on these positive results, Lilly plans to submit for U.S. regulatory approval for pediatric patients with moderate to severe plaque psoriasis.”

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
NHS Scotland accepts AbbVie’s Skyrizi (risankizumab) (Pharmafield) – Oct 8, 2019 – “NHS Scotland accepts AbbVie’s SKYRIZI (risankizumab) in a positive Detailed Advice Document published by the Scottish Medicine Consortium….It confirms that SKYRIZI (risankizumab) is recommended for the treatment of moderate to severe psoriasis in adult patients”

 

Cosentyx (secukinumab) / Novartis
Novartis real-world evidence confirms high efficacy, long-term response and favorable safety profile of Cosentyx in clinical practice (Novartis Press Release) – Oct 9, 2019 – “These extensive results confirm what has been previously observed in Phase 3 clinical trials, and support our continued use of Cosentyx in psoriatic disease…Real-world evidence and observational studies help to bridge the gap in knowledge that exists between clinical trials and clinical practice….These data are being presented at the 28th Congress of the European Academy of Dermatology and Venereology (EADV), 9-13 October 2019, Madrid, Spain.”

 

bimekizumab (UCB4940) / UCB; Cimzia (certolizumab pegol) / Astellas, Dermira, UCB
UCB showcases wealth of new psoriasis research at EADV 2019 (UCB Press Release) – Oct 9, 2019 – “UCB…today announced new data on…CIMZIA® (certolizumab pegol), in psoriasis and psoriatic arthritis (PsA) will be presented at the 28th European Academy of Dermatology and Venereology congress (EADV) in Madrid, October 9-13, 2019….New 60-week data on novel investigational molecule bimekizumab, from the BE ABLE Phase 2 clinical development program, will be shared in an oral presentation.”

 

Stelara (ustekinumab) / J&J; Siliq (brodalumab) / Bausch Health, Leo Pharma, Kyowa Hakko Kirin
LEO Pharma to highlight data at 28th Congress of the European Academy of Dermatology (EADV) (LEO Pharma Press Release) – Oct 9, 2019 – “LEO Pharma…today announced that data from company-sponsored, health economic outcome and investigator-initiated studies will be presented at the 28th annual Congress of the European Academy of Dermatology (EADV), Oct. 9-13, in Madrid, Spain.”

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim; Humira (adalimumab) / Eisai, AbbVie
AbbVie announces new data from its dermatology portfolio and pipeline at the 28th European Academy of Dermatology and Venereology (EADV) congress (PRNewswire) – Oct 9, 2019 – “AbbVie…today announced that it will present new results evaluating the safety and efficacy of SKYRIZI™ (risankizumab) at 2.5 years in adult patients with moderate to severe plaque psoriasis, as well as…upadacitinib, at the 28th European Academy of Dermatology and Venereology (EADV) Congress, October 9-13, in Madrid….In addition, Phase 2b results evaluating time to treatment response with upadacitinib…under investigation for patients with moderate to severe atopic dermatitis will be shared as an oral presentation.”

 

Taltz (ixekizumab) / Eli Lilly; mirikizumab (LY3074828) / Eli Lilly
Lilly to unveil new data for the treatments of complex dermatological conditions at the 28th Annual European Academy of Dermatology and Venereology (EADV) Congress (PRNewswire) – Oct 8, 2019 – “Eli Lilly and Company…announced today that it will present new data for Taltz® (ixekizumab), Olumiant® (baricitinib) and mirikizumab at the 28th annual European Academy of Dermatology and Venereology (EADV) Congress taking place Oct. 9-13 in Madrid, Spain…Lilly will present findings from a Phase 3 trial of Taltz for pediatric patients with moderate to severe psoriasis….Posters to be shared around Lilly’s investigational compound, mirikizumab, include research from a study measuring patient outcomes and health-related elements of quality of life for individuals with moderate to severe psoriasis.”

 

Stelara (ustekinumab) / J&J
Stelara patent expiry: September 2023 in US (Edison Investment Research) – Oct 11, 2019 – A subscription to Thomson ONE is required to gain full access to report 68038761; Page no: 4; REPORT TITLE: “Formycon – H119 results – FYB201 FDA filing imminent”; AUTHOR: Savin, John, et al; DATE: 10/02/2019

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