valvulopathy

"Longer term Phase III trials will be needed to help put the issue of valvulopathy to rest," Wei said.

Arena's Obesity Drug Prospects Look Strong 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.

Arena's Obesity Drug Prospects Look Strong 2006

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.

Lorcaserin’s Path to Approval -- Seeking Alpha 2010

"In our view, any valvulopathy signal is extremely concerning," LeCroy said Tuesday in a note to investors.

SFGate: Top News Stories Rob Waters 2010

Nowhere in the CRL response press release we received from Arena does it indicate anything regarding additional data required to rule out valvulopathy.

Lorcaserin’s Path to Approval -- Seeking Alpha 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."

Lorcaserin’s Path to Approval -- Seeking Alpha 2010

Lorcaserin caused no significant increase compared to placebo in the incidence of new cardiac valvulopathy.

RedOrbit News - Technology 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."

SFGate: Top News Stories Rob Waters 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.

RedOrbit News - Technology 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.

SFGate: Top News Stories Rob Waters 2010