Posted by Michael Wonder on 24 May 2017
Accelerated approval and expensive drugs — a challenging combination
24 May 2017 - For serious or life-threatening disease, the FDA can approve drugs on the basis of surrogate end points that are “reasonably likely to predict clinical benefit,” through its accelerated approval review track.
This pathway, which dates back to the early 1990s, was designed as a response to the demand for faster drug development in the context of the HIV/AIDS crisis.
Since then, the accelerated-approval program has expanded to include oncology products and drugs for other diseases, now accounting for about 10% of new drug approvals.
