Update for May 10, 2023
We recently added 16 new drugs to the knowledgebase:
The FDA approved omidubicel (Omisirge, Gamida Cell), on 4/17,2023, to reduce the time to neutrophil recovery and the incidence of infection. In patients with hematologic malignancies planned for umbilical cord blood transplantation following myeloablative conditioning. Omidubicel was approved with a boxed warning regarding infusion reactions, graft versus host disease, engraftment syndrome, and graft failure.
The FDA approved tofersen (QALSODY, Biogen), on 4/25/2023, for the treatment of amyotrophic lateral sclerosis (ALS) in adults who have a mutation in the superoxide dismutase 1 (SOD1) gene.
The FDA approved a fecal microbiota product (Vowst, Seres Therapeutics), on 4/26/2023, for the prevention of recurrent C. difficile infection.
The FDA approved GSK’s respiratory syncytial virus vaccine (Arexvy), on 5/3/2023, to prevent lower respiratory tract infection caused by RSV in individuals 60 and older.
The FDA rejected concizumab and requested additional information related to monitoring, dosing and the manufacturing process.
The FDA granted a Fast Track designation to VE303 for the prevention of recurrent Clostridioides difficile infection.
The FDA’s Antimicrobial Drugs Advisory Committee voted 12-0 to recommend approval of the combination of sulbactam and durlobactam for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused bysusceptible strains of Acinetobacter. Sulbactam/durlobactam has a PDUFA date of May 29, 2023.
The FDA has placed a hold on Sun Pharma’s deuruxolitinib 12 mg due to a report of a pulmonary embolism in a long-term Open Label Extension (OLE) study. The gold does not affect the 8 mg dose, since no thrombotic events have been reported with the lower dose.
The European Commission granted marketing authorization for vadadustat (Vafseo, Akebia Therapeutics) for the treatment of anemia in chronic kidney disease (CKD) dialysis patients.
Roche obtained zinpentraxin in February 2020, when it bought Promedior. Roche discontinued development of zinpentraxin, in February 2023, as a treatment for idiopathic pulmonary fibrosis after a futility analysis failed to find a benefit compared to placebo. In April 2023, Roche also abandoned development of zinpentraxin to treat myelofibrosis as part of a pipeline review and reprioritization.
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