Weekly Top News – Psoriasis – July 13, 2020

July 13, 2020

imsidolimab (ANB019) / AnaptysBio
AnaptysBio Announces Orphan Drug Designation of Imsidolimab For Treatment of Generalized Pustular Psoriasis (GlobeNewswire) – Jul 8, 2020 – “AnaptysBio, Inc….today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for imsidolimab…for the treatment of patients with GPP….Treatment of GPP by imsidolimab is being evaluated in the GALLOP Phase 2 trial, where additional clinical data and a regulatory update is anticipated in the second half of 2020.”

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
Efficacy and Safety of Tildrakizumab Compared to Placebo in Subjects With Active Psoriatic Arthritis I (INSPIRE 1) (clinicaltrials.gov) – Jul 7, 2020 – P3; N=472; Recruiting; Sponsor: Sun Pharma Global FZE; Not yet recruiting –> Recruiting

 

Avsola (infliximab-axxq) / Amgen
Canada approves infliximab and filgrastim biosimilars Avsola and Nivestym (GaBI) – Jul 10, 2020 – “Canada’s drug regulator, Health Canada, has approved the infliximab and filgrastim biosimilars Avsola (ABP 710) and Nivestym.”

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
Efficacy and Safety of Tildrakizumab Compared to Placebo in Anti-TNF naïve Subjects With Active Psoriatic Arthritis II (INSPIRE 2) (clinicaltrials.gov) – Jul 7, 2020 – P3; N=292; Recruiting; Sponsor: Sun Pharma Global FZE; Not yet recruiting –> Recruiting

 

Stelara (ustekinumab) / J&J
Joint Letter to CMS Advocates Against Adding Stelara to Self-Administered Drug List (The Rheumatologist) – Jul 6, 2020 – “Most recently, the ACR partnered with the Coalition of State Rheumatology Organizations and the Arthritis Foundation to send a letter to the Centers for Medicare & Medicaid Services requesting that it review the Medicare Administrative Contractors’ (MACs) decision to add this drug to the SAD list. Keeping Stelara off the list is important to ensure continued access for patients who can’t self-administer….Implementation is now planned for 45 days after the end of the public health emergency….ACR advocacy efforts will continue to prioritize protecting patient access to Stelara under Medicare Part B.”

 

Hulio (adalimumab biosimilar) / Mylan, Fujifilm Kyowa Kirin Biologics
Mylan and Fujifilm Kyowa Kirin Biologics Announce U.S. FDA Approval of Hulio (adalimumab-fkjp) (PRNewswire) – Jul 9, 2020 – “Mylan…and Fujifilm Kyowa Kirin Biologics Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved Hulio® (adalimumab-fkjp)…for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis (4 years and older), psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis, in both prefilled syringe and auto-injector presentations….In accordance with its patent license agreement with AbbVie, Mylan will be able to launch Hulio in the U.S. during July 2023.”

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