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…
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.
(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…
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.
Subcutaneous tocilizumab is the first biologic agent approved by the FDA treat patients with systemic sclerosis-associated interstitial lung disease.
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.
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.
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.
Three FDA representatives discuss new drug indications, safety precautions and label changes, & an emergency program to rapidly evaluate existing immunomodulating therapies for use in COVID-19 patients.
The FDA issued an emergency use authorization for the use of baricitinib combined with remdesivir to treat patients hospitalized with COVID-19.