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Search results for: romosozumab

FDA Advisory Committee Votes in Favor of Romosozumab Approval

Michele B. Kaufman, PharmD, BCGP  |  January 30, 2019

An FDA advisory committee voted 18-1 in favor of approving romosozumab to treat postmenopausal women with osteoporosis.

Filed under:ConditionsDrug UpdatesOsteoarthritis and Bone Disorders Tagged with:boneFDAOsteoporosisromosozumabU.S. Food and Drug Administration (FDA)

Romosozumab Improves Bone Mineral Density in Men with Osteoporosis

Anne Harding  |  July 7, 2018

NEW YORK (Reuters Health)—Romosozumab improves bone mineral density (BMD) in men with osteoporosis, but safety concerns are holding up its approval in the U.S. Up to 2 million men in the U.S. have osteoporosis, and up to 13 million have osteopenia, researchers note in a report online June 20 in The Journal of Clinical Endocrinology…

Filed under:ConditionsDrug UpdatesOsteoarthritis and Bone Disorders Tagged with:bone mineral density (BMD)FracturesmenOsteoporosisromosozumab

Romosozumab Has Biggest BMD Benefit in First Year of Treatment

Anne Harding  |  May 14, 2018

NEW YORK (Reuters Health)—Romosozumab shows smaller benefits for increasing bone mineral density (BMD) in the second year of treatment compared to the first, new research suggests. The extension of a phase 2 study in postmenopausal women with low bone mass also found BMD decreased sharply when patients on romosozumab were switched to placebo after two…

Filed under:ConditionsDrug UpdatesOsteoarthritis and Bone Disorders Tagged with:bone mineral density (BMD)humanized monoclonal antibodyOsteoporosisosteoporosis treatmentsphase 2 studypostmenopausal womenromosozumab

Rheumatology Drug Updates: Uncertain Future for Romosozumab, Plus FDA Approves Tocilizumab for GCA

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

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…

Filed under:ConditionsDrug UpdatesOsteoarthritis and Bone Disorders Tagged with:amputationApprovalsbonecanagliflozindrugFDAFracturesGiant Cell ArteritisMedicationMyocardial infarctionNSAIDOsteoporosisrheumatologyriskromosozumabSafetytocilizumabTreatment

FDA Update: Romosozumab’s Uncertain Future; Plus Tocilizumab Approved for GCA

Michele B. Kaufman, PharmD, BCGP  |  June 9, 2017

Due to possible heart-related side effects, romosozumab is no longer expected to be approved this year for the treatment of osteoporosis…

Filed under:Biologics/DMARDsConditionsDrug UpdatesOsteoarthritis and Bone Disorders Tagged with:FDAFood and Drug AdministrationFracturesgiant cell arteritis (GCA)heartOsteoporosisromosozumabside effecttocilizumab

Romosozumab Promising for Osteoporosis Treatment; Setbacks for Fulranumab Clinical Trials

Michele B. Kaufman, PharmD, BCGP  |  April 27, 2016

Two studies have shown that romosozumab is effective for increasing bone mineral density in both men and women with osteoporosis. And due to safety concerns, Janssen has dropped out of clinical trials for fulranumab, which is being studied to treat OA pain…

Filed under:Biologics/DMARDsConditionsDrug UpdatesOsteoarthritis and Bone Disorders Tagged with:menOsteoporosisromosozumabWomen

The ACR Addresses the FDA about the Safe Adoption of Biosimilars in the U.S.; Plus Tofacitinib Approved for RA & Romosozumab May Reduce Fracture Risk

Michele B. Kaufman, PharmD, BCGP  |  March 9, 2016

The ACR has continued its advocacy to ensure the safe adoption of biosimilars in the U.S., most recently addressing an FDA public hearing. Also, the FDA has approved tofacitinib for RA, and a clinical trial of romosozumab for patients with osteoporosis met its primary endpoint…

Filed under:Biologics/DMARDsDrug Updates Tagged with:American College of Rheumatology (ACR)BiosimilarsFDAFood and Drug AdministrationinfliximabromosozumabTofacitinibtofacitinib citrate

New Labeling for Infused Golimumab; Phase 3 Trial for Romosozumab Promising

Michele B. Kaufman, PharmD, BCGP  |  September 16, 2015

The FDA has approved new labeling for infused golimumab to include measures of mental and physical health. Plus romosozumab meets primary endpoints in postmenopausal women with osteoporosis during a Phase 3 trial…

Filed under:Biologics/DMARDsConditionsDrug UpdatesOsteoarthritis and Bone Disorders Tagged with:combination therapyFDAFood and Drug AdministrationGolimumabInjectionMental HealthMethotrexateOsteoporosispostmenopauseromosozumab

ACR Responds to Aetna Specialty Pharmacy Requirements

From the College  |  June 7, 2025

Aetna recently notified practices about the launch of its Combined Benefit Management Drug List, which will result in romosozumab-aqqg (Evenity) and infliximab (Remicade) moving to pharmacy-only coverage on July 1. The ACR is working to oppose this change.

Filed under:Legislation & AdvocacyPractice Support Tagged with:ACR advocacyspecialty drug acquisition

Fracture & an Aging World

Jason Liebowitz, MD, FACR  |  September 24, 2024

Insights into osteoporosis treatments as societies around the world age.

Filed under:ConditionsEULAR/OtherMeeting ReportsOsteoarthritis and Bone Disorders Tagged with:APLARAPLAR 2024Asia Pacific League of Associations for Rheumatology (APLAR)bisphosphonatesdenosumabdrug holidayOsteoporosisosteoporosis treatmentsromosozumabzoledronic acid

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