Differences in Timeline of European and US Approval of Drugs


I had a question the other day - paraphrased it was 'Why do you focus on US approvals for the great ChEMBL-og drug monographs; don't you miss things in Europe?'. Well for an admittedly small subset, here's the reason.

The graph above is the difference (in years) between approval in the US and Europe, for all worldwide approved protein kinase inhibitors (N=30). 28 of these are approved in the US, and 20 in Europe - and all of these 20 are approved in the US (as of 16th August 2013). As you can see, typically drugs are approved around a year later in Europe than in the US, and no examples from this set show the reverse behaviour. The two 'Japan only' compounds are Fasudil and Umirolimus (remember, we include the rolimus class - but they're not the classical small molecule kinase inhibitors).

Caveat - the data is initial, and I haven't gone through and checked every data point yet, but things won't change a lot. I'll also go through and add Japan to this analysis when I have a little more free time....

Update - the initial data from Japan is quite different, there are a few (so far) where Japan approves NME prior to the rest of the World. Anyway, more later....

jpo