Switzerland-based Novartis has revealed mixed results in the EXCEED phase 3b trial that has been assessing Cosentyx (secukinumab) in active psoriatic arthritis in comparison to Abbvie's Humira (adalimumab), it was reported yesterday.
The product is an inhibitor of interleukin-17A (IL-17A). It could not show statistical significance for superiority in ACR 20 over the AbbVie drug in the head-to-head late-stage trial. Due to this the product fell short of meeting the primary endpoint for ACR20 response rates at Week 52. The company stated that its IL-17A inhibitor indicated numerically higher results compared to Humira. It also showed statistically significant advantages over Humira in PsA-specific endpoints in a pre-specified sensitivity analysis, according to the company. According to Novartis, Cosentyx maintained a consistent and favourable safety profile, which was similar to what was observed in previous clinical trials.
The EXCEED trial included more than 800 biologic-naive patients with PsA and is a 52-week, multi-centre, randomised, double-blind, active control study.
The US Food and Drug Administration (FDA) has already approved Cosentyx for the treatment of psoriasis, PsA and ankylosing spondylitis.
Corcept announces receipt of FDA Complete Response letter for relacorilant in hypercortisolism
Axsome Therapeutics secures FDA priority review for AXS-05 in Alzheimer's disease agitation
Vanda's NEREUS approved by US FDA for prevention of motion sickness
Diamyd Medical agrees accelerated efficacy readout in ongoing Phase 3 type 1 diabetes trial
INOVIO's INO-3107 Biologics License Application accepted by US FDA
Citius Pharmaceuticals reports full-year financial results
Bioeq and Zydus partner for US commercialisation of Lucentis biosimilar NUFYMCO
Sanofi receives FDA complete response letter for tolebrutinib in progressive MS
Aqualung Therapeutics' Phase 2a lung fibrosis study approved by US FDA
AstraZeneca secures US Breakthrough status for Enhertu in early breast cancer
Shield Therapeutics wins FDA approval to expand ACCRUFeR use to adolescents
ECO Animal Health Group secures EU approval for ECOVAXXIN MS
Hansa Biopharma submits imlifidase Biologics License Application to FDA
T-MAXIMUM Pharmaceutical receives IND approval to start Phase II trial of MT027 for rGBM
Alvotech and Teva secure US launch date for Eylea biosimilar AVT06