Adults with complicated urinary tract infections (cUTIs) and limited or no alternative treatment options could soon receive Shionogi & Co. Ltd.'s cefiderocol following FDA approval for the antibacterial. The approved indication also included kidney infections caused by susceptible gram-negative microorganisms. The new therapy, to be marketed as Fetroja, is expected to be available in early 2020.
The FDA's Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) unanimously concluded Thursday that Amarin Corp. plc provided sufficient evidence of efficacy and safety to support approval of fish oil-based Vascepa (icosapent ethyl) for an indication to reduce the risk of cardiovascular (CV) events in adults with elevated triglyceride levels (≥135 mg/dL) and other risk factors for CV disease. The 16-0 vote followed a day's discussion about potential effects of mineral oil, about the proper age population and the value of labeling. EMDAC's conclusion is only an advisory, as the FDA makes the final decision. FDA representatives at the panel discussion noted the study provided convincing data and waived off most concerns about mineral oil's impact on LDL cholesterol levels and blood pressure.
Nanthealth Inc. has received U.S. FDA clearance for a whole exome sequencing test to determine overall tumor mutational burden (TMB) in cancer tissue. Known as Omics Core, the first-of-its-kind in vitro diagnostic test is available now as part of Nanthealth's GPS Cancer molecular profiling suite.
Nearly a month ahead of the PDUFA date, red blood cell maturation drug luspatercept cleared the FDA for treating anemia in adults with beta-thalassemia who require regular red blood cell (RBC) transfusions. Branded Reblozyl, the drug, developed in a collaboration between Celgene Corp. and Acceleron Pharma Inc., is expected to be available in one week following approval.
BEIJING – Chinese biosimilar maker Bio-Thera Solutions Ltd., of Guangzhou, said its BAT-1406 became the first biosimilar referencing Abbvie Inc.'s blockbuster TNF-blocker, Humira (adalimumab), to win a marketing nod in China. It is Bio-Thera's first biosimilar and China's second homegrown biosimilar approved by the National Medical Products Administration (NMPA).
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