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Search results for: Sarilumab

FDA Approves Sarilumab for pJIA

Michele B. Kaufman, PharmD, BCGP  |  July 29, 2024

The FDA has granted sarilumab its first pediatric indication, approving the agent to treat active, polyarticular juvenile idiopathic arthritis (pJIA) in patients who weigh at least 63 kgs.

Filed under:Biologics/DMARDsConditionsDrug UpdatesPediatric Conditions Tagged with:FDA approvalpJIApolyarticular juvenile idiopathic arthritis (JIA)sarilumabU.S. Food and Drug Administration (FDA)

Study Assesses Sarilumab for Polymyalgia Rheumatica

Ruth Jessen Hickman, MD  |  January 25, 2024

In an ACR Convergence 2022 session, Robert Spiera, MD, director of the Scleroderma, Vasculitis, and Myositis Center at the Hospital for Special Surgery, New York City, discussed the use of sarilumab as a potential glucocorticoid-sparing therapy in a phase 3 study in patients with treatment-refractory polymyalgia rheumatica (PMR), one of the most common inflammatory diseases…

Filed under:Biologics/DMARDsConditionsDrug UpdatesOther Rheumatic ConditionsResearch Rheum Tagged with:IL-6IL-6 inhibitorsPMR FocusRheumPolymyalgia RheumaticaResearch Reviewsarilumabsteroid-sparing therapies

FDA Approves Sarilumab for Adults with Glucocorticoid-Resistant Polymyalgia Rheumatica

Michele B. Kaufman, PharmD, BCGP  |  January 25, 2024

On Feb. 28, 2023, the U.S. Food & Drug Administration (FDA) approved sarilumab (Kevzara) for the treatment of adults with polymyalgia rheumatica (PMR) for whom glucocorticoids have proved inadequate or who cannot tolerate a glucocorticoid taper.1,2 Sarilumab is an interleukin (IL) 6 receptor antagonist. In May 2017, the FDA initially approved the agent for the…

Filed under:Biologics/DMARDsConditionsDrug UpdatesOther Rheumatic ConditionsResearch Rheum Tagged with:glucocorticoid resistantIL-6IL-6 inhibitorsPMR FocusRheumPolymyalgia RheumaticaResearch Reviewsarilumab

FDA Approves Sarilumab for the Treatment of Adults with Glucocorticoid-Resistant PMR

Michele B. Kaufman, PharmD, BCGP  |  March 14, 2023

Sarilumab is now FDA approved to treat adults with polymyalgia rheumatica who have had an inadequate response to glucocorticoids or who cannot tolerate a glucocorticoid taper. This new indication is based on results from the multicenter, phase 3 SAPHYR trial.

Filed under:Drug Updates Tagged with:FDA approvalglucocorticoidPolymyalgia RheumaticasarilumabU.S. Food and Drug Administration (FDA)

Sarilumab Approved for the Treatment of Adults with Glucocorticoid-Resistant PMR

Keri Losavio  |  March 3, 2023

First described in 1888, polymyalgia rheumatica (PMR) is a chronic inflammatory condition that almost exclusively affects individuals older than 50.1 Until this week, no therapies for PMR had been approved by the U.S. Food & Drug Administration (FDA).2 Tuesday, Sanofi announced sarilumab (Kevzara) has been approved by the U.S. Food & Drug Administration for the…

Filed under:ConditionsDrug UpdatesOther Rheumatic Conditions Tagged with:Polymyalgia Rheumaticasarilumab

Sarilumab Trial Data Shows It May Only Help Critical COVID-19 Patients

Saumya Joseph  |  April 27, 2020

(Reuters)—On April 27, Regeneron Pharmaceuticals Inc. and Sanofi SA said on Monday that their arthritis drug sarilumab (Kevzara) may only help the sickest patients with COVID-19, dampening hopes that the therapy could potentially reach a larger pool of patients with the disease. The drugmakers said they would test high doses of sarilumab only in critically…

Filed under:Drug Updates Tagged with:coronavirusCOVID-19sarilumabtocilizumab

Sarilumab Investigated to Treat COVID-19

Michele B. Kaufman, PharmD, BCGP  |  March 23, 2020

A study investigating sarilumab’s effects on patients with COVID-19 has begun in New York. The treatment blocks IL-6, which may play a role in the respiratory distress caused by the virus…

Filed under:Drug Updates Tagged with:clinical trialsCOVID-19sarilumab

Can IL-6 Predict Sarilumab Response?

Michele B. Kaufman, PharmD, BCGP  |  January 2, 2019

Recent post-hoc analyses of two Phase 3 clinical trials show that RA patients with high interleukin 6 levels taking sarilumab experienced improved symptoms and less joint damage than those using other treatments…

Filed under:Drug Updates Tagged with:adalimumabMethotrexatesarilumab

News Updates for Diclofenac Sodium, Denosumab & Sarilumab

Michele B. Kaufman, PharmD, BCGP  |  June 20, 2017

In drug news, a generic 2% diclofenac sodium solution is now available, denosumab is promising to treat osteoporosis, and the FDA has approved sarilumab to treat adults with RA…

Filed under:Biologics/DMARDsConditionsDrug UpdatesOsteoarthritis and Bone Disorders Tagged with:denosumabdiclofenac sodiumFDAFood and Drug Administrationgeneric drugsKnee Osteoarthritis (OA)OsteoporosisRheumatoid Arthritis (RA)sarilumab

Sarilumab Approval Stalled; Piclidenoson Promising for Psoriasis

Michele B. Kaufman, PharmD, BCGP  |  November 16, 2016

Due to manufacturing deficiencies found during a routine inspection by the FDA, approval of sarilumab for treating RA has slowed until facility issues are resolved…

Filed under:Biologics/DMARDsDrug Updates Tagged with:apremilastpiclidenosonPsoriasisRheumatoid Arthritis (RA)sarilumab

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