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.
ACR Update on Tocilizumab Shortages
ATLANTA—The ACR is actively engaged with the U.S. Food & Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) drug shortage team as they work with the manufacturer to resolve current shortages of tocilizumab (Actemra). Demand for tocilizumab has outpaced supply, with demand increasing after the FDA’s June 24 Emergency Use Authorization (EUA) for…
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.
ACR Endorses Woodcock for FDA Commissioner, Begins Relationship Building with New Administration Leaders
With the approval of its Board of Directors, the ACR sent a letter to President Biden and newly minted Secretary of Health & Human Services Xavier Becerra, strongly supporting Janet Woodcock, MD, to be nominated as the FDA’s permanent commissioner. The ACR also congratulated Secretary Becerra upon his confirmation.
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