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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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In the Pipeline: Don't miss Derek Lowe's excellent commentary on drug discovery and the pharma industry in general at In the Pipeline

In the Pipeline

« A Look Inside the Compound Collections | Main | Let the Healing Begin »

May 3, 2011

Lucentis and Avastin: Results

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Posted by Derek

So the results are in from that Lucentis-vs-Avastin comparison (known as CATT, Comparison of AMD Treatment Trials), and I'd say that they came out the way people were expecting: monthly injections of either antibody give the same end results, as measured by vision testing. There are some slight differences between the two when retinal thickness is measured, but that hasn't shown up in the end result (visual impairment). There's another year of follow-up ongoing, and perhaps that will show something (or perhaps not). For now, the outcome appears to be the same.

Another interesting feature of this study is that it compared regular monthly treatment with either drug to an "as-needed" dosing schedule. In this case Lucentis performed equally well by either schedule, with monthly Avastin equivalent, but (interestingly) as-needed Avastin dosing was, in fact, inferior. These protocols need fewer injections (and less Lucentis), but more imaging of the retina, along with more judgment calls on the part of physicians, so the cost savings there will remain to be seen. Savings on injections into the eyes, though, would surely be welcome - it's too bad that Avastin didn't perform as well that way.

As the editorial in the NEJM summed it up:

Health care providers and payers worldwide will now have to justify the cost of using ranibizumab. Regulators in certain countries will be forced to reconsider their policies that make it illegal to use drugs off-label, particularly when so many of their citizens cannot afford ranibizumab. The CATT data support the continued global use of intravitreal bevacizumab as an effective, low-cost alternative to ranibizumab.

The only thing that could flip this around is if the second year of CATT produces some new data, or if the ongoing European trials turn up some safety data that this study wasn't powered to pick up.

More here at the In Vivo Blog. BioCentury also did a good write-up on this one for their subscribers - they interviewed a number of opthamology practitioners, and the voting looks solidly in favor of using the much less expensive Avastin. One South Carolina practice reported that, because of the state's sales tax on physician-administered drugs, that they pay $140 in tax for every injection of Lucentis, while getting reimbursed $120 by Medicare for doing it, which doesn't sound like much of a way to make a living. Still, as the newsletter points out, off-label Avastin use (which would be legal) involves repackaging what was a single-dose container, and that part is technically in violation of the law. Buthe agency doesn't want to get in the way of freedom of medical practice, and seems to be letting that trump the repackaging/compounding concerns.

Comments (5) + TrackBacks (0) | Category: Clinical Trials | Drug Prices


COMMENTS

1. Hap on May 3, 2011 12:32 PM writes...

Does the report on CATT not address safety issues, or weren't there any to speak of?

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2. srp on May 3, 2011 12:35 PM writes...

"But the agency doesn't want to get in the way of freedom of medical practice..." Stop it, you're killing me!

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3. Derek Lowe on May 3, 2011 1:54 PM writes...

Hap, it doesn't appear to have been powered to pick much up, unless something dramatic happened. The European data should settle the issue, though.

Permalink to Comment

4. pete on May 3, 2011 5:35 PM writes...

What a welcome scenario ! One in which Mother Nature has been kind, IMHO. That is, Mr. Surprise Adverse Event (traceable to some Devil's-in-the-details difference in drug behavior) appears to have taken a holiday from this indication.

And in terms of drug pricing, score one for the common man (& woman). It's not an outcome that Genentech-Roche wanted, but much credit to them for all the R&D on these 2 drugs.

Permalink to Comment

5. Jeff on September 12, 2011 10:39 AM writes...

http://www.fda.gov/Drugs/DrugSafety/ucm270296.htm

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