New AcariaHealth Pipeline Report - August 2023

The AcariaHealth August 2023 Pipeline Report is now available, featuring recent and anticipated drug approvals, key changes in the biosimilar agent landscape, and notes on recent and anticipated generic product launches. This issue features the FDA approval for two notable gene therapies – Elevidys (delandistrogene moxeparvovec-rokl) for Duchenne muscular dystrophy, priced at $3.2 million for a single dose, and Roctavian (valoctocogene roxaparvovec-rvox) for severe hemophilia A, priced at $2.9 million for a single dose. Other therapies that were FDA-approved include Beyfortus (nirsevimab-alip) for pediatric respiratory syncytial virus (RSV) prophylaxis in all healthy infants and Leqembi (lecanemab-irmb) conversion to full approval for the treatment of early Alzheimer’s disease. 

In the next quarter, potential FDA approvals are anticipated for two more gene therapies and one autologous cell therapy. The two gene therapies – exagamglogene autotemcel (Vertex Pharmaceuticals) and lovotibeglogene autotemcel (Bluebird Bio)– are proposed for the treatment of severe sickle cell disease. Lifileucel is an autologous cell therapy that is awaiting an FDA decision for its proposed indication for the treatment of advanced melanoma, and would be the first cell therapy to be approved to treat a solid tumor type. There have also been developments in the cases for FDA approval of three potentially significant pipeline agents – donanemab for early Alzheimer’s disease, tirzepatide (currently approved as Mounjaro) for the treatment of type 2 diabetes, and Wegovy (semaglutide) for cardiovascular risk reduction.

Our quarterly publication is developed by our Clinical Pharmacy Drug Information team to help our clients increase their understanding of the drug pipeline, ensuring they are equipped with insights to prepare for shifts in prescription drug management. Learn more by accessing the complete AcariaHealth August 2023 Pipeline Report (PDF).