Two recent trials demonstrated the safety and efficacy of risankizumab-rzaa for the treatment of adults with active psoriatic arthritis.
FDA Approves Secukinumab for Children with Enthesitis-Related Arthritis & PsA
The FDA has approved the use of secukinumab for pediatric patients with enthesitis-related arthritis and psoriatic arthritis, after research showed a longer time to disease flare than placebo.
Considerations for Prescribing Avacopan for ANCA-Associated Vasculitis
In early October, the FDA approved avacopan to treat anti-neutrophil cytoplasmic antibody associated vasculitis. Here are insights into the treatment’s risks and considerations.
FDA Approves Cyltezo, an Interchangeable Biosimilar to Humira
On Oct. 15, the U.S. Food & Drug Administration (FDA) approved the first interchangeable biosimilar product to treat certain inflammatory diseases. Cyltezo (adalimumab-adbm), originally approved in August 2017, is both biosimilar to and interchangeable with (i.e, may be substituted for) its reference product Humira (adalimumab) for Cyltezo’s approved uses. Cyltezo is the second interchangeable biosimilar…
FDA Grants Octapharma 7-Year Market Exclusivity for Octagam 10%
The FDA has granted a seven-year marketing exclusivity for Octagam 10%, a 10% solution of a human intravenous immunoglobulin (IVIG) that treats adults with dermatomyositis.
FDA Approves IVIG to Treat Adults with Dermatomyositis
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.