n clinical trials, tildrakizumab was more effective than etanercept and placebo at treating moderate to severe plaque psoriasis. Adalimumab has received approval for treating non-infectious intermediate, posterior and panuveitis—its 10th FDA indication…
In July, the FDA’s Arthritis Advisory Committee will meet and review proposed biosimilars for etanercept and adalimumab to treat multiple rheumatic diseases…
(Reuters)—Novartis AG’s cheaper version of Amgen Inc.’s arthritis drug etanercept (Enbrel) is highly similar in potency and safety to the original and should be approved, an advisory panel to the U.S. Food and Drug Administration concluded on Wednesday. The panel voted 20–0 that there is no clinically meaningful difference between Novartis’s drug, a biologic made…
Etanercept Submitted for Chronic, Severe Plaque Psoriasis in Children The U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application for etanercept (Enbrel) for treating pediatric patients with chronic, severe plaque psoriasis.1 The application was submitted in early January 2016 and is based on results of a one-year Phase 3 study with…
NEW YORK (Reuters Health)—The anti-tumor necrosis factor (TNF) antibody adalimumab drives regulatory T cell (Treg) expansion in rheumatoid arthritis (RA) by binding to membrane TNF, researchers from the UK report. “These results show that adalimumab enhances the anti-inflammatory actions of TNF to increase regulatory T cell activity,” Dr. Michael R. Ehrenstein from University College London,…
On Nov. 19, 2015, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended granting marketing authorization for SB4, an etanercept biosimilar product that will be called Benepali.1 On Jan. 16, 2016, EMA granted marketing authorization in the European Union for Benepali to be used to treat rheumatoid arthritis (RA), psoriatic…
The FDA has received an application to expand the use of etanercept to treat plaque psoriasis in pediatric patients. Boehringer Ingelheim and AbbVie have announced a collaborative partnership to develop treatments for multiple autoimmune diseases. And gerilimzumab may prove safe and effective for treating inflammatory diseases at very low doses…
Tofacitinib has been released from the FDA’s risk evaluation and mitigation strategy requirement. The FDA is also reviewing a biologics license application for ABP-501, an adalimumab biosimilar. And CHS-0214, a proposed etanercept biosimilar, has met its primary endpoint at Week 24 in an ongoing 52-week study…
An etanercept biosimilar referencing Enbrel and designed to treat multiple autoimmune diseases has been approved for the European market. Also, an application for subcutaneous brodalumab to treat plaque psoriasis has been submitted to the FDA…
NEW YORK (Reuters Health)—Almost half of juvenile idiopathic arthritis (JIA) patients treated with etanercept achieve minimal disease activity after one year of treatment, according to new findings. Younger patients and those who did not require corticosteroid treatment were more likely to have an excellent response, Dr. Kimme Hyrich of the University of Manchester in the…