"Longer term Phase III trials will be needed to help put the issue of valvulopathy to rest," Wei said. ❋ Unknown (2006)
Arena, however, is confident its drug stimulates the 5-HT2C receptor and not the closely related 5-HT2B, which the company believes is associated with cardiac valvulopathy. ❋ Unknown (2006)
BLOOM-DM does not change the overall assessment of valvulopathy. ❋ Matthew Herper (2010)
"In our view, any valvulopathy signal is extremely concerning," LeCroy said Tuesday in a note to investors. ❋ Rob Waters (2010)
They met the guideline for efficacy, ruled out valvulopathy and the overall adverse event profile is excellent. ❋ Unknown (2010)
Please note that valvulopathy was not included in the CRL. ❋ Unknown (2010)
All Arena investors expected the biggest discussion point at the Advisory Committee and within the hallways of the FDA, to be whether or not Arena ruled out an increased risk of valvulopathy. ❋ Unknown (2010)
BioMedTracker puts the p-value a measure of statistical significance for the valvulopathy risk in this study at 0.068 - meaning such an answer would occur by chance 7 times out of 100. ❋ Matthew Herper (2010)
"In light of lorcaserin's limited efficacy, the concerns over rodent mammary tumors and the new numerical increase in valvulopathy ... we are removing lorcaserin from our valuation of Arena as we now assume the drug is unapprovable." ❋ Rob Waters (2010)
I think they did about as much as they could do [to rule out valvulopathy.] ❋ Unknown (2010)
Arena should be addressing with more than the assertion that it has put the valvulopathy issue to bed. ❋ Unknown (2010)
The FDA had 3 cardiologists on the panel since valvulopathy was to be a major discussion point, but not a SINGLE expert on the panel that could speak to the neoplasm risk, a decision the FDA said they later "regretted." ❋ Unknown (2010)
Lorcaserin caused no significant increase compared to placebo in the incidence of new cardiac valvulopathy. ❋ Unknown (2010)
Nowhere in the CRL response press release we received from Arena does it indicate anything regarding additional data required to rule out valvulopathy. ❋ Unknown (2010)
Unfortunately, BLOOM-DM can be seen as changing whether Arena has ruled out valvulopathy, as the BioMedTracker analysis shows. ❋ Unknown (2010)
Patients underwent echocardiography at screening, and at 6, 12, 18 and 24 months after initiating dosing in the trial; patients with FDA-defined valvulopathy were excluded from enrolling in the trial. ❋ Unknown (2010)
At the end of the yearlong study, 2.9 percent of patients had signs of valvulopathy, a disorder of the heart's valves, compared with 0.5 percent of those taking placebos, Arena said. ❋ Rob Waters (2010)
This trial by itself was not powered to detect meaningful differences in the incidence of valvulopathy. ❋ Unknown (2010)
