lunes, 16 de septiembre de 2019

Next up for Aimmune: FDA approval?

The Readout
Damian Garde

Next up for Aimmune: FDA approval?

That’s all but guaranteed following the lopsided support for the peanut allergy treatment Palforzia from experts on Friday’s FDA advisory panel. Yeah, there were some dissenting opinions, but the 7-2 panel vote coupled with 90 minutes of “We want this approved now!” public testimony from parents of kids with severe peanut allergies has put Aimmune in a very comfortable spot. The FDA has until January to make the approval decision. Will it take that long? 
With approval a gimme, the Aimmune peanut allergy story shifts to Palforzia pricing, insurance reimbursement, and commercial uptake. Aimmune hasn’t disclosed a price yet, but analysts as a group are guessing around $4,200 for one year of therapy. If you do the rough math on the amount of peanut protein in a year’s worth of Palforzia treatment, it works out to be about $20 per peanut. Nuts?

No hay comentarios: