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Search results for: etanercept

FDA Panel Supports Novartis Biosimilar of Etanercept

Reuters Staff  |  

(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…

Rheumatology Drug Updates: Etanercept for Pediatric Plaque Psoriasis

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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…

Etanercept Submitted to FDA for Approval to Treat Pediatric Plaque Psoriasis; Boehringer Ingelheim & AbbVie to Collaborate; Low Doses of Gerilimzumab Promising for RA

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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 Released from FDA REMS Requirement; Plus Biosimilars for Etanercept & Adalimumab Show Promise

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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…

Etanercept Biosimilar Approved in EU, Plus FDA Reviews Brodalumab for Plaque Psoriasis

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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…

Disease Duration, Corticosteroid Use Predict Etanercept Response in JIA

Reuters Staff  |  

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…

Methotrexate Halt Feasible in Some Etanercept RA Responders

David Douglas  |  

NEW YORK (Reuters Health)—Certain rheumatoid arthritis (RA) patients doing well on etanercept and methotrexate may be able to quit the latter agent if they have tolerability problems, according to an open-label Canadian study. In a Sept. 11 online paper in Rheumatology, Dr. Boulos Haraoui, of the University of Montreal, and colleagues noted that although combination…