Wyeth-Ayerst's Verdia Cleared By FDA Panel

The US Food and Drug Administration's Cardiovascular and Renal DrugsAdvisory Committee has voted 9-2 to recommend approval of Wyeth-Ayerst's once-daily angiotensin II receptor blocker, Verdia (tasosartan), for the treatment of hypertension. However, the panel did express concerns about the potential for hepatic adverse events with use of the drug.

In US trials, Verdia was found to cause high levels of the liver enzyme transaminase in 1.8% of the 4,400 patients who were otherwise asymptomatic. The drug has been tested in more than 6,000 patients worldwide, the company said, and the most frequently-reported adverse events seen in clinical trials were headache and dizziness, which occurred at placebo-equivalent rates.

A spokesman for Wyeth-Ayerst told the Marketletter that no other data from the trials were available. He did note that a wide array of preclinical data had been presented at the advisory panel hearing which demonstrated no symptoms of liver impairment in animals which had very long exposures to the drug at more than 50 times the human dose. Although tasosartan has been studied at doses of 25mg, 50mg and 100mg (and data were shown at all these doses), there is, as yet, no definitive dose, he said.