An array of new and expanded indications of therapeutics for rheumatic disease last year relied on pharmacokinetic modeling for intravenous dosing and efficacy extrapolation for pediatric populations.
Rheumatology Drug Updates: Hip Fracture Rates After Bisphosphonate Drug Holidays, Plus More on Golimumab, Ustekinumab
Bisphosphonate Drug Holidays Drug holidays are common for patients on bisphosphonate therapy. Often, these breaks in treatment are related to known U.S. Food and Drug Administration (FDA) warnings and drug class adverse effects. Currently, data on fracture risk related to drug holidays are limited. In recent research highlighted at the 2017 ACR/ARHP Annual Meeting ,…
Rheumatology Drug Updates: Biosiomilar to Adalimumab Receives FDA Approval; plus Updates on Baricitinib, Tofacitinib, Bimekizumab
FDA Approves Adalimumab-adbm On Aug. 29, the FDA approved Cyltezo (adalimumab-adbm), a biosimilar to Humira (adalimumab).1 Cyltezo was approved as a prefilled syringe to treat multiple chronic inflammatory diseases, including moderate to severe active RA, active psoriatic arthritis and ankylosing spondylitis, and moderate to severe plaque psoriasis. The treatment has also been approved for moderate…
Abatacept Approved for Psoriatic Arthritis in Adults; Sirukumab Approval Stalls
Abatacept Approved for Adult PsA On June 30, the U.S. Food and Drug Administration (FDA) approved abatacept (Orencia) to treat adults with active psoriatic arthritis (PsA).1 Abatacept is available as both an intravenous formulation and a subcutaneous injection.2 The approval was based on results of two randomized, double-blind, placebo-controlled trials, PsA-I and PsA-II, during which…
Rheumatology Drug Updates: Opana ER Painkiller Pulled from U.S. Market; Upadacitinib to Treat RA, and More
Opana ER Pulled from U.S. Market Last month, the U.S. Food and Drug Administration (FDA) asked Endo Pharmaceuticals to remove oxymorphone hydrochloride extended release (Opana ER) from the U.S. market due to public health consequences related to abuse. The agency has concerns that the risks presented by the treatment do not outweigh its benefits.1 On…
Rheumatology Drug Updates: Uncertain Future for Romosozumab, Plus FDA Approves Tocilizumab for GCA
Romosozumab’s Future Is Uncertain Romosozumab, which has the possible U.S. brand name Evenity, is awaiting approval from the FDA.1 The treatment is an investigational, injectable biologic for treating osteoporosis. It increases bone formation and bone density, reducing a patient’s risk of fractures. The manufacturer no longer expects the FDA to approve the drug this year…
FDA Responds to New Drug Application for Baricitinib
Oxycodone Tablets Submitted to FDA Filings for oxycodone tablets (Oxaydo) in both 10 and 15 mg doses have been accepted by the U.S. Food and Drug Administration (FDA).1 The submission is based on a pharmacokinetic study demonstrating bioequivalence to the reference drug, oxycodone hydrochloride (Roxicodone) tablets at a 15 mg dose. The product is an…
FDA Drug Labeling, Approval Process Help Minimize Lawsuits Against Pharmaceutical Companies
Like many people, I am up early and in the gym most days. Although I don’t seem to get anywhere new on the stationary bicycle or the elliptical machine, I do get to keep up with the pundits on the early morning talk shows. In contrast to the television series I binge on later in…
Rheumatology Drug Updates: Efficacy & Safety of Guselkumab, Plus FX006 for Knee OA
Guselkumab Improves Active Psoriatic Arthritis New research has revealed that patients with active psoriatic arthritis (PsA) and ≥3% body area of plaque psoriasis benefit from treatment with a human monoclonal antibody known as guselkumab (GUS). GUS is specific for the p19 subunit of interleukin 23 (IL-23). Patients in the Phase 2 clinical trial experienced significant…
Rheumatology Drug Updates: Giant Cell Arteritis Relapse Possible if Tocilizumab Discontinued; Plus Updates on Rituximab, Etanercept
GCA Relapse Possible When Discontinuing Tocilizumab In a Phase 2 randomized, controlled trial, tocilizumab, an anti-IL-6 biologic agent, was shown to induce and maintain remission for up to 52 weeks in patients with giant cell arteritis (GCA).1 During this trial, patients with GCA were randomized in a 2:1 ratio to receive 8 mg/kg bodyweight tocilizumab…
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