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May 11, 2010
Regulatory Approvals in the US versus Europe
I was looking at the list the other day of the 2009 drug approvals from the FDA. Here's a breakdown from Nature Reviews Drug Discovery - 25 total, 16 small molecules and 9 biologics. And here, from the same journal, is a look at approvals in Europe. There were 29 - but the weird thing is that only five entries overlap on the two lists. The authors of this latest article suggest that this raises questions about global strategy.
Does it? Let's break that down. Here are the small molecules approved by the FDA in 2009 that were not approved in the EU:
Milnacipran: was already on the market in Europe for depression, approved in the US for fibromyalgia.
Febuxostat: approved by the EU in late 2008, by the FDA in early 2009.
Artemether–lumefantrine: approved by the EU back in 2001.
Benzyl alcohol (Ulesfia), of all things, for head lice: not yet approved in the EU.
Iloperidone: approved (most unexpectedly) in the US, not even submitted yet in Europe, as far as I know. May never be.
Besifloxacin (opthalmic): not approved in the EU yet.
Prasugrel: apparently didn't make the list because the CHMP in Europe approved it in December 2008.
Pitavastatin: expected to be approved in the EU this year, and has been in Japan since 2003.
Asenapine: still under review in the EU.
Vigabatrin: approved for infantile spasms in the US, but has been approved as an antiepileptic in Europe since 1989 and in the US since 1997.
Bepotastine: not approved in the EU yet, although I think that's underway.
Telavancin: has had a complicated past in the EU - basically, they have approval against hospital-acquired pneumonia as part of the EU application, while in the US it's part of a separate add-on.
Pralatrexate: approved for lymphoma in the US, and under review in the EU.
Pazopanib: under review in the EU.
Romidepsin: under review in the EU as well.
So overall, it's not as much of a split as it looks. Several compounds are just missing showing up in the same calendar year, and if you did this analysis using a two-year window, I think the overlap would be much greater. Admittedly, for some drug launches every day counts, so ideally you'd want approval for both the US and EU to come soon and simultaneously, but mostly, things are reasonably close. The next thing to do will be to look at the compounds on the EU approval list and see how they stand in the US - no time for me to do that today, but shortly.
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