About this Author
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: Twitter: Dereklowe

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In the Pipeline

« Six Sigma in Drug Discovery? Part One - Are Chemists Too Individual? | Main | The Life of a Key Opinion Leader »

September 16, 2010

Live-Blogging Arena's FDA Committee Hearing

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Posted by Derek

San Diego newspaper blogger Keith Darce is doing it here. The meeting should start up again about 1 PM Eastern. So far, the company and the FDA staff have been presenting reviews of the Lorcaserin data. The committee member questions don't look particularly encouraging. . .

Update: the committee votes "No", 9-5. We'll see what the agency itself does. I expect the same outcome.

Comments (7) + TrackBacks (0) | Category: Diabetes and Obesity | Regulatory Affairs


2. anchor on September 16, 2010 1:10 PM writes...

..this is almost like watching Gore V Bush!

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3. HappyDog on September 16, 2010 2:04 PM writes...

Regarding the FDA staffer's comment about the patient that attempted suicide while on Lorcaserin, does this mean that embezzlement will have to appear on the label as a possible side effect if the drug is approved?

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4. In Vivo Veritas on September 16, 2010 2:04 PM writes...

You called it Lowe - voted down.

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5. glinkst on September 17, 2010 9:19 AM writes...

So what is the lowedown? No chance for approval? The response for orexigen is interesting. Market is saying arena's problems are arena's and not obesity as an indication.
As a pure guess only, it suggests that the animal tumor data may have weighed more than some of the other side effects. The lowest dose administered in rats showed an effect, which is not good. The other side effects seemed managable IMUHO.

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6. not a chemist on September 20, 2010 2:10 PM writes...

IMHO, any anti-obesity drug that has psychiatric side effects has a snowball's chance in hell as far as FDA approval goes. How someone came up with such a dim idea as topiramate + amphetamine analog and thought they'd have a winner, I'll never know. (Disclaimer: I have used topiramate for psychiatric indications. It isn't the best in class for the particular indication I was taking it, but it is - unlike most other psychiatric drugs - a great weight loss aid, and definitely not a drug to be taken lightly.)

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7. Evorich on September 20, 2010 5:02 PM writes...

In the end it's risk vs. reward, and for something to have such a small reward and have any risk - it just ends up being not worth approving.

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