After a long and tortuous development Astrazeneca plc’s anifrolumab has been approved by the FDA for the autoimmune disease systemic lupus erythematosus (SLE), setting up a rivalry with its U.K.-based counterpart Glaxosmithkline plc. The first-in-class type 1 interferon receptor antibody, the first new drug for the disease in a decade, will be marketed under the brand name Saphnelo for adults with moderate to severe disease who are receiving standard therapy.
Prostate cancer affects roughly 1 in 9 American men in their lifetime, with 174,650 new cases reported each year. However, current prostate specific antigen (PSA) tests lack specificity, leading to overdiagnosis and overtreatment of inconsequential cancers. Cleveland Diagnostics Inc. is looking to change that with its IsoPSA assay, which just received a breakthrough device designation from the U.S. FDA. In clinical studies, the noninvasive, blood-based test has been shown to have higher accuracy than standard PSA tests.
Briefing documents released ahead of Wednesday’s meeting of the FDA’s Antimicrobial Drugs Advisory Committee, slated to review Shionogi & Co. Ltd.’s cefiderocol for treatment of complicated urinary tract infections (cUTIs), spotlighted a finding of increased mortality among critically ill cefiderocol-treated patients in the company’s Credible-CR study.