FDA actions in brief, May 2009 (Coartem, Ixiaro, Lexapro, Reclast, Symbyax)

Aucatzyl is a CAR T-cell therapy that targets CD19 and has been designed to minimize excessive activation of the programmed T cells. There is no word yet on the wholesale acquisition cost.

For the first time, Skyrizi has replaced Humira as AbbVie’s sales driver, largely due to companies encouraging “product hopping” to avoid competition, creating concerns for the sustainability of the burgeoning adalimumab biosimilar market.

An FDA advisory committee last year agreed that the data do not support phenylephrine as an effective nasal decongestant.

If approved, donidalorsen would be a first-in-class RNA-targeted medicine for hereditary angioedema. The agency’s goal date is August 21, 2025.

In the ESSENCE trial, semaglutide improved liver fibrosis in patients with metabolic dysfunction-associated steatohepatitis (MASH).

Committee members said there was uncertainty around sotagliflozin in patients with kidney disease. The FDA is currently reviewing the oral therapy as an adjunct to insulin to help control glycemic levels in adults with type 1 diabetes and chronic kidney disease. The agency’s goal date is Dec. 20, 2024.