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Articles tagged with "FDA"

Rheumatology Drug Updates: Infliximab Biosimilar Gets FDA Approval & More

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April 5, 2016, marks a revolutionary day in the treatment of autoimmune diseases: The U.S. Food and Drug Administration (FDA) approved an infliximab (Remicade) biosimilar, known as Inflectra (infliximab-dyyb). Infliximab-dyyb, which is administered by intravenous infusion, is the first biosimilar drug approved to treat rheumatic disease in the U.S.1 Infliximab-dyyb has received approval for almost…

Tofacitinib Promising for Psoriatic Arthritis & FDA Issues Alert for Warning for Saxagliptin & Alogliptin Diabetes Treatments

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A recent Phase 3 study found tofacitinib safe and effective for treating psoriatic arthritis at both 5 mg and 10 mg doses compared with placebo. And the FDA has added label warnings to saxagliptin and alogliptin for an increased risk of heart failure in individuals taking the drugs, particularly in those with heart and kidney disease…

OA Knee Pain Treatment Enters Clinical Trials, Ixekizumab Receives FDA Approval & Belimumab Promising for SLE Patients

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Clinical trials have begun to determine if disodium zoledronate tetrahydrate is safe and effective for treating pain in patients with knee osteoarthritis. The FDA has approved the use of ixekizumab for the treatment of plaque psoriasis. And a study has shown that patients with SLE treated with belimumab may be able to decrease steroid use…

Opinion: Politics Should Not Trump Science in Medicine

John A. Goldman, MD  |  

I tell my patients there are three types of science: 1) investigative science, which sometimes gets it right; 2) science in the courtroom, which is junk science; and 3) science in Washington, D.C., which is political science. Our decisions are based on art and science; our patients’ medications are brought to market based on science….

Biosimilars Debate Heats up over Cost Savings, Safety Concerns

Biosimilars Debate Heats up over Cost Savings, Safety Concerns

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After years of speculation about potential cost savings and debates on safety, biosimilars are about to step onto the stage of rheumatic disease treatment. On Feb. 9, the Arthritis Advisory Committee of the U.S. Food and Drug Administration (FDA) met in Washington, D.C., and recommended the approval of CT-P13, a proposed biosimilar to infliximab (Remicade),…

Rheumatology Drug Updates: Biosimilars Receive Positive News & More

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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…

Remicade Antibodies Cross-React to Biosimilars

Lorraine L. Janeczko  |  

NEW YORK (Reuters Health)—Patients with antibodies to infliximab in Remicade should not be switched to biosimilars, researchers warn. “(The) antibodies will cross-react with the new biosimilar drug, potentially reducing clinical response,” Dr. Daniel Nagore, director of research and development at Progenika Biopharma in Derio, Spain, told Reuters Health by email. “The study highlights the importance…

FDA Approves Biosimilar to J&J’s Remicade for Multiple Diseases

Reuters Staff  |  

(Reuters)—The U.S. Food and Drug Administration on Tuesday approved Inflectra, a cheaper version of Johnson & Johnson’s drug Remicade (infliximab), to treat Crohn’s disease, ulcerative colitis, rheumatoid arthritis, psoriasis and arthritis of the spine. Inflectra, also known as infliximab-dyyb, is expected by some analysts to sell for a 25% discount to Remicade, which generated annual…