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It was suggested by a poster yesterday that most drugs that have their marketing decisions go down to the wire at the FDA are rejected or delayed.

I thought I’d examine the evidence for this. Due to time constraints, I limited my enquiry to orphan drug marketing approval decisions made by the FDA in the first quarter of last year, as listed here.

Findings

There were 10 orphan drugs with assigned PDUDA dates in Q1 last year.

Half (5) of the decisions were announced on the assigned PDUFA date. Of these, 2 were approvals and 3 were CRLs. Of the CRLs received on the PDUFA date, one was for Reata Pharmaceuticals’ drug, bardoxolone. Last month, Reata again had to wait until the PDUFA date for a decision on another drug, omaveloxolone. This time, it received an approval.

Four received early replies. Two were approvals, one was a CRL and one was a decision to extend the PDUFA date.

One decision was late (by 3 days). It was an approval.

Hence, of the 5 approvals, 2 were early, 2 were on PDUFA and 1 was late.

Of the 5 non-approvals, 2 were early, 3 were on PDUFA and none was late.

Limited data obviously but certainly not suggestive that going down to the wire is mostly associated with rejection or delay.