Search results for: Sarilumab

U.S. FDA Panel Votes Against Approval of Arthritis Drug Sirukumab

Toni Clarke | August 2, 2017

(Reuters)—The benefits of Johnson and Johnson’s experimental rheumatoid arthritis drug sirukumab do not outweigh the risks, an advisory panel to the U.S. Food and Drug Administration concluded on Wednesday. The panel voted 12-1 that the drug should not be approved, citing safety concerns, including an imbalance in the number of deaths in patients taking sirukumab…

EULAR Releases 2016 Recommendations on RA Management

Mary Beth Nierengarten | July 14, 2017

Management of rheumatoid arthritis (RA) is complex. The ever-expanding availability of new drugs requires that rheumatologists and patients constantly consider treatment strategies and targets aimed at both disease control and symptom relief while remaining cognizant of the increasing high cost of emerging medications. Given such complexity, guidelines to inform rheumatologists about the most recent developments…

Institute for Clinical Economic Review Final Report on RA Treatments

Mary Beth Nierengarten | May 4, 2017

On April 7, 2017, the Institute for Clinical and Economic Review (ICER) published its final report, titled, Targeted Immune Modulators for Rheumatoid Arthritis: Effectiveness & Value.1 The stated objective of the report was to assess the comparative clinical effectiveness of the targeted immune modulators (TIMs) used to treat patients with moderate to severe active rheumatoid…

EMA Panel Recommends Nod for Sanofi, Regeneron’s Arthritis Drug

Reuters Staff | April 24, 2017

(Reuters)—A European Medicines Agency panel said on Friday it recommended granting marketing approval to Sanofi and Regeneron’s experimental drug to treat rheumatoid arthritis (RA). The Committee for Medicinal Products for Human Use gave a positive opinion on the drug, sarilumab (Kevzara), citing its ability to reduce the signs and symptoms of RA. Sarilumab, the active…

Celecoxib Is a Safe Treatment for Arthritis

Lara C. Pullen, PhD | February 20, 2017

A study compared celecoxib with ibuprofen and naproxen to determine its cardiovascular safety, as well as gastrointestinal and renal outcomes, in patients with rheumatoid arthritis and osteoarthritis. The results showed that celecoxib met all prespecified noninferiority requirements and is as safe as other non-selective NSAIDs…

Rheumatology Drug Updates: Biosimilars Seek Regulatory Approval in the U.S., Europe; Methotrexate Underused

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

Biosimilars Receive Positive News 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 If approved, Benepali can be used to treat rheumatoid arthritis (RA), psoriatic arthritis (PsA), axial spondyloarthritis and plaque psoriasis….

Biosimilar Drugs for RA Studied in Multiple Trials

Michele B. Kaufman, PharmD, BCGP | August 17, 2015

Etanercept Biosimilars A number of Phase 3 trials are ongoing for etanercept biosimilars.1 One evaluation identified three trials in rheumatoid arthritis (RA) patients and one in psoriasis patients. The psoriatic arthritis trial evaluated PASI as a primary endpoint and the following secondary endpoints: PASI50, PASI75, PASI90, PASI score, laboratory values, ECG, adverse events (AEs), injection…