After a study investigated if hydroxycholoroquine (HCQ) benefits COVID-19 patients, the drug—used to treat SLE and RA patients—began running out in pharmacies around the U.S. ACR leaders have asked the FDA to increase monitoring of the HCQ supply…
Search results for: Sarilumab
Regeneron Plans Early Summer Trials for New Antibodies Against Coronavirus
(Reuters)—Regeneron Pharmaceuticals Inc. said on Tuesday it had identified hundreds of antibodies that could treat or prevent the coronavirus (COVID-19) and was preparing to begin clinical trials by early summer, sending the drugmaker’s shares up 12%. The company will select the top two antibodies to develop a “cocktail” treatment and scale up its manufacturing to…
Sanofi, Regeneron Begin Testing Arthritis Drug as Coronavirus Treatment
(Reuters)—Sanofi SA and partner Regeneron Pharmaceuticals Inc. have started a clinical trial of their rheumatoid arthritis drug Kevzara (sarilumab) as a treatment for the coronavirus, the companies said on Monday. Enrolments for the mid-to-late stage trial will begin immediately, and the companies anticipate the trial will test up to 400 patients. Sarilumab is an infection-fighting…
Otilimab Begins Phase 3 Clinical Studies for RA
In a four-part clinical trial program, researchers are assessing the safety and efficacy of otilimab with placebo in RA patients, along side conventional treatments, such as tofacitinib, and DMARDs…
Rheumatology Drugs at a Glance, Part 3: Rheumatoid Arthritis
Over the past few years, biosimilars and other new drugs have been introduced to treat rheumatic illnesses. Some of the conditions we treat have numerous drug options, others have few or only off-label options. This series, “Rheumatology Drugs at a Glance,” provides streamlined information on the administration of biologic, biosimilar and small molecule inhibitor drugs…
The FDA Approved Several New Rheumatology Drugs in 2017
SAN DIEGO—In a session at the 2017 ACR/ARHP Annual Meeting, Kam Nola, PharmD, MS, professor in the College of Pharmacy and vice chair in the Department of Pharmacy Practice at Lipscomb University in Nashville, Tenn., updated participants on new medications and new indications for rheumatology treatments and safety labeling changes approved by the U.S. Food…
U.S. FDA Panel Votes Against Approval of Arthritis Drug Sirukumab
(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
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
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)—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…