Wyeth-Ayerst Withdraws Verdia NDA

Wyeth-Ayerst has announced that it is withdrawing the New DrugApplication for its once-daily angiotensin II receptor blocker Verdia (tasosartan) because of "an unresolved question arising from ongoing discussions with the Food and Drug Administration regarding the safety profile."

The surprise move comes after an advisory panel last month recommended by a nine-to-two vote that the FDA approve the drug (Marketletter February 9). At the time, the panel did express concerns about hepatic adverse events with the drug, but concluded that Wyeth-Ayerst had been more thorough in its testing for high levels of liver enzyme transaminase than other companies and should not be penalized for this. However, it did conclude that labeling should mention the risk associated with the product.

A company spokesman told the Marketletter that the NDA had been withdrawn in order to open the door to discussions with the FDA, the focal point of which will be the liver enzyme elevation issue. This will allow time to determine the exact meaning of the data and make a decision about progressing with the product.