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Home » BIO Report: Drug Candidates Have 1 in 10 Chance of Gaining FDA Approval
BIO Report: Drug Candidates Have 1 in 10 Chance of Gaining FDA Approval
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June 1, 2016
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.
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