Don't Believe the Obesity Hype

• Report this Comment On May 28, 2011, at 3:59 PM, PhillyDan wrote:

  Brian, once again you have proven what a fool you are!! Why you ask?

  1. You should know that the meta-analysis was done for the benefit of the EMEA. The EMEA unlike the FDA, pays more attention to the effectiveness of any drug on sub-groups. As the data proves Lorcaserin is very effective in these sub-groups;.

  As an example if 25% of all people (completers was 35%) in the three studies lost 10% or greater of their weight, then imagine (if you can) that this is extrapolated up to ten million people. Would you say that between 2.5M and 3.5M people losing 10% or greater isn't a good thing?

  2. "Arena has an obese to-do-list." It is obvious that you have not been paying attention to the last two CCs and the very good presentation that Christen Anderson, VP of Lorcaserin Development gave at the BOA/ML Healthcare Conference in Las Vegas.

  Had you paid attention you would have found out that your "obese to-do-list" is now a "slim-to-do-list"!

  a. Bloom-DM study completed and results compiled. Arena filed this as an IND with the FDA, so the FDA has to look at the data now. The results will be filed with the resubmitted NDA, but the FDA will have to review the IND and comment on the results. BTW, type II diabetics have a difficult time losing weight, but a significant number in the study lost weight. In addition, the HbA1c and Fasting Glucose levels were greatly reduced.

  b. The five independent pathologists have completed the re-adjudication of the rat slides submitted in the original NDA, where the FDA cited diagnostic un-certainty. The CRO is finalizing the report and it could be out any day now. If you are keeping count, that is two items of the CRL completed.

  c. The ten-person study for obtaining CSF (cerebral spinal fluid) has been completed. The ten people in this study took Lorcaserin for a week, then a spinal tap was done to acquire the fluid. The analysis of this fluid is ongoing.

  d. Additional receptor studies of the 5HTa and b receptors is ongoing. These additional studies are being done to further define the selectivity of Lorcaserin to the a and b receptors.

  e. Additional abuse liability studies have been completed or are still on-going. All of these studies should be completed shortly.

  d. Arena has been working directly with the FDA to finalize the protocols and study design of the 3-month prolactin effect study. In fact, as I type, this may be already finalized and the studies may be underway.

  In addition, Arena is running several experimental studies to on the "prolactin effect" and probably is why they are confident that a 12-month study is not required. Recommend you do some homework and read some of the excellent posts by Dr. Daniel on the YMB. Then you will understand why a 12-month study is not needed.

  Two items completed. Two other items underway and probably will be completed within 30-45 days.

  The last item will take 3-months or less for the study and probably 45 days for the results to be compiled by the CRO.

  At least 60 to 70+ percent of the CRL work has been completed. In my opinion, Arena will refile by the end of this year, probably in November which would mean a PDUFA date in May/June 2012.

  Recommend you read Janet Woodcock's comments in a recent interview where she is quoted as saying with respect to the weight loss drugs. Even those drugs with a modest weight loss should be considered for approval if there are other benefits and the sub-groups analysis shows that the drugs can help a lot of people lead healthier lives. Other benefits like reduced HbA1c, Fasting Glucose, lower Cholesterol, lower BP and lower HR. Which have been shown in the data presented by Ms. Anderson at the ECO conference in Turkey.

  I will leave it up to the readers who has provided the more detailed analysis of what has transpired.

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