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.
FDA Authorizes New Long-Acting, Monoclonal Antibodies for Pre-exposure Prevention of COVID-19 in Certain Individuals
On Dec. 8, the U.S. Food & Drug Administration (FDA) issued an emergency use authorization (EUA) for AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab and administered together) for the pre-exposure prophylaxis (prevention) of COVID-19 in certain adults and pediatric individuals (12 years of age and older weighing at least 40 kilograms [about 88 pounds]). The product…
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 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…
14 Rheumatology Treatments Make Top 50 List of Drugs That Can Cause Anaphylaxis
A recent study of data from the FDA’s Adverse Event Reporting System reveals that 14 drugs commonly prescribed by rheumatologists are on the list of the top 50 drugs that can cause anaphylaxis.
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.
Health Canada Approves CT-P13 SC for RA; Plus Tofacitinib May Increase Cardiac & Cancer Risks
In Canada, a subcutaneous formulation of CT-P13, which is biosimilar to infliximab, was approved to treat rheumatoid arthritis.
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