medwireNews : The US FDA has issued an Emergency Use Authorization permitting use of the interleukin (IL)-1 receptor antagonist anakinra to treat certain hospitalized patients with severe COVID-19.

medwireNews : The US FDA has announced that the indication for belimumab will be expanded to include active lupus nephritis in children and adolescents aged 5–17 years.

medwireNews : The US FDA has issued an updated safety communication announcing that boxed warnings on the labels for tofacitinib, baricitinib, and upadacitinib must be updated to include information on the risk for serious cardiovascular (CV) events, cancer, blood clots, and death.

This FDA approval is based on findings from the placebo-controlled KEEPsAKE 1 and 2 trials , which showed that risankizumab significantly improved a range of PsA outcomes.

On the basis of findings from the ORAL Surveillance study , the FDA has restricted the use of tofacitinib to patients with an inadequate response to at least one TNF inhibitor for all indications.

medwireNews : The US FDA has approved upadacitinib for the treatment of adult patients with active psoriatic arthritis (PsA) and an inadequate response or intolerance to at least one tumor necrosis factor (TNF) inhibitor.

medwireNews : The US FDA has approved adalimumab-adbm as the first interchangeable biosimilar drug to treat inflammatory arthritis and certain other immune-mediated diseases.

The FDA notes that avacopan “does not eliminate glucocorticoid use.”

Eric Morand gives his thoughts on the FDA approval of anifrolumab for SLE and discusses the need for additional studies to understand exactly how the drug should be used in routine clinical practice

The US FDA has approved intravenous immunoglobulin for the treatment of dermatomyositis in adults.

medwireNews : The US FDA has approved anifrolumab-fnia for the treatment of adult patients with moderate-to-severe systemic lupus erythematosus (SLE) who are receiving standard therapy.

medwireNews : The US FDA has updated its Emergency Use Authorization (EUA) for baricitinib, and the Janus kinase (JAK) inhibitor is now permitted to be used for the treatment of COVID-19 without the requirement for remdesivir co-medication.

medwireNews : The US FDA has issued an Emergency Use Authorization permitting the use of tocilizumab for the treatment of some hospitalized patients with severe COVID-19.

medwireNews : Tocilizumab has been approved by the US FDA for slowing the rate of decline in respiratory function in patients with systemic sclerosis (SSc)-associated interstitial lung disease (ILD).

medwireNews : The US FDA has approved belimumab as the first drug treatment for adult patients with active lupus nephritis.

The FDA is currently reviewing the available data and plans to issue recommendations following completion of the review.

medwireNews : The US FDA has issued an Emergency Use Authorization permitting the use of the Janus kinase (JAK) inhibitor baricitinib, in combination with remdesivir, for the treatment of COVID-19.

Previously approved for the treatment of adults with rheumatoid arthritis, tofacitinib is the first JAK inhibitor to be approved by the FDA for a pediatric population.

medwireNews : The US FDA has expanded the label for the tumor necrosis factor (TNF) inhibitor golimumab to include two pediatric indications.

medwireNews : The US FDA has approved another adalimumab biosimilar – adalimumab-fkjp – for the treatment of various rheumatic diseases.