ARNA Investors: May 2012

FDA BD Synopsis by Dr. Daniel Lopez Link to this article on YMB

http://messages.finance.yahoo.com/Stocks_%28A_to_Z%29/Stocks_A/threadview?m=tm&bn=1339&tid=281086&mid=281086&tof=2&frt=2

Here is a summary of the FDA BD First I must disclose that I didn’t have the time to do an in depth analysis of the 248 pages but I did read it all. The following is a summary of key findings: Valvulpathy The receptor potency study provides supportive evidence that lorcaserin is not a valvulopathogen at the clinical dose of 10 mg twice daily. This in addition to the echocardiogram studies provides evidence that there is no valvulopathy risk. Carcinogenicity KEY point: FDA is satisfied that prolactin is the MOA for the higher incidence of fibroadenomas. As I have mentioned many times, prolactin, even in small doses, is responsible for increased incidence of fibroadenomas and the FDA examiner concurs. KEY point: PWG findings completely negated the rationale for combining benign and malignant tumors CRL #1: Diagnostic uncertainty PWG results definitive and therefore confirms that the only cancer risk is at the 100mg/kg dose of lorcaserin providing a safety margin of 24-fold and the FDA is satisfied this confers no human risk and therefore no MOA needed. CRL#2 Exposure-response relationship for lorcaserin-emergnet mammary adenocarcinoma Increased incidence of lung metastasis in the mid and high dose groups is equivocal, with no difference between control and low dose groups. What they didn’t say is important. Though there was an increase in lung mets in the mid and high dose the fact that was left out is that there were no statistically significant increases in other tumors found in rats. These tumors may have been responsible for the lung mets but because there was no statistically significant increase in other types of tumors they basically are stating this is not an issue With regard to increase in fibroadenomas they did make that statement that the clinical risk due to these tumors is less than adenocarcinoma. They almost made the statement that a tumorigenic MOA was not necessary. So people let’s put to rest the idea of a 12 month study – let it RIP. However, they did evaluate the MOA presented by Arena and though the results of the prolactin study were not impressive, they were sufficient to satisfy the proposal by Arena that prolactin was the MOA. However, as I mentioned, they intimated that the MOA was probably not necessary to determine human risk. And again, they agree that it only takes a minimal increase in prolactin to explain the increased incidence of fibroadenomas. Sound familiar to those who have read my posts? CONTINUE The Science Will Prevail Daniel UCLA MD Links to BD documents
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM303198.pdf

http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM303199.pdf

ARNA Investors

Saturday, May 12, 2012

Media jumping on Lorcaserin/ARNA bandwagon

Wednesday, May 9, 2012

FDA BD Synopsis by Dr. Daniel Lopez