Update for June 1, 2023

Regulatory Update


The FDA approved sulbactam and durlobactam (Xacduro, Innoviva), on 5/23/2023, for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex (Acinetobacter).

The FDA approved sotagliflozin (Inpefa, Lexicon Pharmaceuticals), on 5/26/2023, to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure in adults with heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors.

The FDA approved Pfizer’s respiratory syncytial virus vaccine (Abrysvo), on 5/31/2023, to prevent lower respiratory tract infection caused by RSV in individuals 60 and older.

The FDA is delaying the PDUFA date for delandistrogene moxeparvovec by one month in order to consider an accelerated approval for Duchenne patients ages 4-5 years old. The new PDUFA date is 6/22/2023. Full approval and expansion to other age groups or withdrawal from the market will depend on the results of the Phase III EMBARK trial. The EMBARK trial is forecast to report top-line results by the end of the year.

The FDA accepted the NDA for fruquintinib for the treatment of refractory metastatic colorectal cancer and set a PDUFA date for 11/30/2023.

The FDA accepted the BLA for lifileucel for the treatment of unresectable or metastatic melanoma and set a PDUFA date for 11/25/2023