As in past administrations, members of the Executive Committee scheduled meetings with leaders of the Food & Drug Administration and Centers for Medicare & Medicaid Services to discuss ACR policy priorities and agency agendas.
Cilnidipine Receives Orphan Drug Status to Treat Systemic Sclerosis
Based on research showing improved signs and symptoms of systemic sclerosis in patients taking cilnidipine vs. placebo, the FDA granted orphan drug designation for the agent.
Nipocalimab Receives Breakthrough Therapy Status for Sjögren’s Disease
Nipocalimab, an investigational monoclonal antibody that blocks FcRn and reduces levels of circulating immunoglobulin G (IgG) antibodies, has received the FDA’s breakthrough therapy designation for the treatment of Sjögren’s disease.
FDA Approves Suzetrigine (VX-548), a Non-Opioid Analgesic
Based on research in post-surgery patients, the FDA approved suzetrigine, a non-opioid analgesic, for the treatment moderate to severe, acute pain in adults.
mRNA CAR T Cell Therapy Receives FDA’s Rare Pediatric Designation to Treat Juvenile Dermatomyositis
FDA has granted Descartes-08, an mRNA chimeric antigen receptor T cell therapy, a rare pediatric disease designation for the treatment of juvenile dermatomyositis.
FDA Approves Bimekizumab-bkzx (Bimzelx) for 3 New Rheumatic Indications
The FDA has approved bimekizumab-bkzx for the treatment of adults with psoriatic arthritis, non-radiographic axial spondyloarthritis and ankylosing spondylitis.
FDA Officials Discuss Extrapolation & Confusion Around Pediatric Therapies
A session at ACR Convergence 2024 addressed several recent drug approvals in pediatric rheumatology and a safety update for IL-1/IL-6 inhibitors.
FDA Accepts New Drug Application for Suzetrigine, a Non-Opioid Analgesic
The FDA accepted a new drug application for suzetrigine, a non-opioid analgesic, based on the results from clinical trials in patients with neuropathy and those post-surgery.
FDA Approves 2 Upadacitinib Formulations for Children with pJIA & PsA
Upadacitinib, as a tablet and oral solution, is now FDA approved to treat children age 2 years and older with active polyarticular juvenile idiopathic arthritis or psoriatic arthritis.
FDA Approves Sarilumab for pJIA
The FDA has granted sarilumab its first pediatric indication, approving the agent to treat active, polyarticular juvenile idiopathic arthritis (pJIA) in patients who weigh at least 63 kgs.
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