FDA approves 5 new costly drugs well ahead of PDUFA dates
Since 21 October, the FDA has been on a tear in approving five new drugs (all with list prices of more than $100,000 per year) months ahead of when they were expected to be approved.
For instance, the FDA signed off on Vertex Pharmaceuticals’ Trikafta (elexacaftor/ivacaftor/tezacaftor), a new treatment for those with the most common cystic fibrosis mutation, after only three months of review and well ahead of its 19 March 2020 user fee action date.
To read Endpoints News become a free subscriber
Unlock this article instantly, along with access to limited free monthly articles and our suite of newsletters