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DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: derekb.lowe@gmail.com Twitter: Dereklowe

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May 11, 2010

Regulatory Approvals in the US versus Europe

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Posted by Derek

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.

Comments (12) + TrackBacks (0) | Category: Regulatory Affairs


COMMENTS

1. Jay on May 11, 2010 1:57 PM writes...

Benzyl alcohol for head lice? I presume as a topical application... maybe this will be the new advertising campaign?

http://www.theonion.com/articles/johnson-johnson-introduces-nothing-but-tears-shamp,2506/

Permalink to Comment

2. The Pharmacoepidemiologist on May 11, 2010 2:46 PM writes...

At one time, an EU-US comparison was a fair one. No longer. The tolerance for risk in the EU is much better these days than in the US. I'm not talking law suits either (though the EU may trump the US in that regard too). US FDA has essentially been told by Congress that it's safety over everything else. Have you tried getting a meeting with FDA lately? It's a far longer wait than PDUFA requires, and if you protest to the agency, you get hit with the response of "Go cry to Congress and see if we care." Some of this focus on safety over all else is the public's response to some of the screwiest marketing efforts the industry came up with. So it's no surprising. But given that bent in the US (and it's been taking hold for several years now), I don't think that one can fairly compare EU approvals with US ones. The playing fields are just too different.

Permalink to Comment

3. biotech investment paradigm on May 11, 2010 5:25 PM writes...

I can agree with #2. IND's are usually submitted to the EU first, with a seemingly more "accepting" agency. I'd expect the approval gap (time between the EU and US) to continue to widen as the FDA's requirements become more and more stringent.

Permalink to Comment

4. Wilks on May 11, 2010 6:28 PM writes...

If you hadn't had enough of hating Pfizer, here's another reason (#456).

More layoffs...

http://www.nytimes.com/2010/05/11/nyregion/11pfizer.html?scp=2&sq=pfizer&st=cse

Permalink to Comment

5. MTK on May 11, 2010 10:23 PM writes...

Derek,

Sounds like time for a Venn diagram!

Permalink to Comment

6. Still Scared of Dinosaurs on May 12, 2010 6:59 AM writes...

Not sure # of INDs is the right measure. My experience is that Phase 1 is very easy to start in England but that has little bearing on which side of the Atlantic the development focuses on.

That focus is often crucial. FDA worships placebo control and EMEA is openly hostile to it, and I worked on one drug for which giving each agency what it wanted was practically impossible. So, natch'ly, we followed the path to us approval, but this was a while ago.

I often think a sponsor would be better off developing sister molecules in parallel tailored to the two approaches. Probably a good strategy except for that whole cost thing.

Permalink to Comment

7. ChemNerd on May 12, 2010 8:42 AM writes...

Derek, I notice that you do quite a bit of hyperlinking to Wikipedia such as in this blog post. I'm curious what you think of Wikipedia and the quality of its articles in the the chemistry/pharmacology field. Presumably your linking means that you find the article quality sufficient for this type of use, but what about for more serious work-related use? Is it useful, accurate, or thorough enough for a research scientist? Do you contribute to Wikipedia yourself, or know of any colleagues that do? (Perhaps a blog post soon, I humbly suggest.)

Permalink to Comment

8. Dylane on May 12, 2010 12:30 PM writes...

So the overlap that does occur though is concentrated in the biologic space. It looks like there are 4 biologics that were approved in both the EU and US in 2009, out of 9 total for the US? If I'm reading that right that is, I don't have access to the Nature article, so I'm working back a bit from your list.

Permalink to Comment

9. Regulatory in UK on May 13, 2010 1:39 AM writes...

Re Still Scared of Dinosaurs, first of all, many of the EU guidelines actually [i]recommend{/i] placebo control in their clinical trials, so it all depends very much on a)the indication and b)the country. Even in countries which are traditionally hostile to placebo control, providing a good justification for its use, even referencing FDA guidelines is often successful.

Also, the IND system is particular to the FDA (and other systems modelled on it, e.g. Korea, Philippines, especially since it renamed its RA the FDA - obviously didn't think to check if that name was already taken!) so literally comparing them isn't realistic when comparing Europe.

Finally just to point out: England and the UK aren't interchangeable terms - England is one part of the UK, as are Scotland, Wales and Northern Ireland and members of the latter three don't appreciate being labelled as "England". The MHRA serves the UK, not just England.

Permalink to Comment

10. Regulatory in UK on May 13, 2010 1:40 AM writes...

Re Still Scared of Dinosaurs, first of all, many of the EU guidelines actually [i]recommend[/i] placebo control in their clinical trials, so it all depends very much on a)the indication and b)the country. Even in countries which are traditionally hostile to placebo control, providing a good justification for its use, even referencing FDA guidelines is often successful.

Also, the IND system is particular to the FDA (and other systems modelled on it, e.g. Korea, Philippines, especially since it renamed its RA the FDA - obviously didn't think to check if that name was already taken!) so literally comparing them isn't realistic when comparing Europe.

Finally just to point out: England and the UK aren't interchangeable terms - England is one part of the UK, as are Scotland, Wales and Northern Ireland and members of the latter three don't appreciate being labelled as "England". The MHRA serves the UK, not just England.

Permalink to Comment

11. petros on May 14, 2010 7:32 AM writes...

Some interesting points but its better to remember that NDAs and MAAs are frequently not filed concurrently, which hinders such analysis.

But a recent case highlights the discrepancy.
n 2009 Nycomed filed for approval of the PDE4 inhibitor rofluimilast for the treatment of COPD (a major, and poorly treated, disease). In April 2010 the CHMP recommended approval of the MAA but the same month the FDA's advisory panel voted 10-5 against approval citing insufficient evidence of efficacy.

Permalink to Comment

12. Still Scared of Dinosaurs on May 14, 2010 9:05 AM writes...

R in UK - I am aware that the UK and England are not interchangeable but from my experience it seems like all Phase 1 work outside the US is done at Guy's so maybe my focus was too broad.

And, yeah, you can do active control in US and placebo in Europe (can I include the UK in Europe in this context?) but the default is pretty much as I stated. My core point was that outsiders don't have much of a clue as to how many decisions we make along the way that constitute compromises between optimal EMEA versus FDA strategy...and sometimes the rest of the world gets into the mix as well. Looking at approval rates without knowing what strategic decisions were made - knowing that the tendency has been to tilt towards US approval - doesn't generate a meaningful comparison, IMHO.

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