In July, the FDA approved the use of Octagam 10%, an intravenous immunoglobulin solution, to treat dermatomyositis in adults after an international study demonstrated the treatment’s safety and efficacy.
AbbVie, Lilly Face New Delays in FDA Approval for Expanded Use of Janus Kinase Inhibitors
(Reuters)—AbbVie Inc. and ELi Lilly & Co. are facing fresh delays in the approval of their respective rheumatoid arthritis (RA) drugs for treating the chronic skin disease eczema as the U.S. health regulator assesses the new class of treatment over safety concerns. The treatment, called Janus kinase inhibitors (jakinibs), blocks inflammation-causing enzymes known as Janus…
FDA Approves Tocilizumab to Treat Systemic Sclerosis-Associated ILD
Subcutaneous tocilizumab is the first biologic agent approved by the FDA treat patients with systemic sclerosis-associated interstitial lung disease.
FDA Approves Belimumab & Voclosporin for Lupus Nephritis
In December, the FDA approved belimumab, the first drug approved to treat lupus nephritis, an historic action that was rapidly followed in January by the approval of a second treatment for lupus nephritis, voclosporin.
FDA Approves New Rituximab Biosimilar & Anakinra to Treat a Rare Disease
The FDA has approved anakinra to treat a rare autoinflammatory disease, deficiency of interleukin 1 receptor antagonist. The administration also approved a new rituximab biosimilar, Riabni, for multiple indications.
FDA Approves Golimumab for Patients with pJIA & Psoriatic Arthritis
The FDA has approved golimumab for the treatment of pediatric patients with active polyarticular juvenile idiopathic arthritis or active psoriatic arthritis…
Guselkumab Approved for PsA
Based on data from two clinical trials, the FDA has approved guselkumab to treat adult patients with active psoriatic arthritis…
FDA Approves Secukinumab for Non-Radiographic Axial Spondyloarthritis
In June, the FDA approved secukinumab to treat non-radiographic axial spondyloarthritis after data from a clinical trial demonstrated its efficacy…
FDA Approves Tremfya (Guselkumab) for Adult Patients with Psoriatic Arthritis
HORSHAM, PA—The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved Tremfya (guselkumab) for adult patients with active psoriatic arthritis (PsA), a chronic progressive disease characterized by painful joints and skin inflammation.1,2 Tremfya is the first treatment approved for active PsA that selectively inhibits interleukin (IL)…
FDA Approves the Biosimilar Hadlima (Adalimumab-bwwd)
Hadlima (adalimumab-bwwd), which is biosimilar to adalimumab, is now FDA approved to treat multiple autoimmune diseases…