BIO Report: Drug Candidates Have 1 in 10 Chance of Gaining FDA Approval

A 10-year review of over 7,000 drug development programs found that candidates have a roughly one in 10 chance of securing FDA approval.

The report found the overall likelihood of approval for all developmental candidates in Phase 1 trials to be 9.6 percent, with that number climbing to 11.9 percent if oncology candidates are excluded. The paper — which covers results from 2006 to 2015 — was commissioned by BIO.

Non-oncology rare disease candidates were found to be particularly successful, with a 25.3 percent approval rate, 2.6 times higher than for all disease categories.