US FDA cardio panel firmly rejects Bristol-Myers Squibb's Vanlev

Surprising many analysts, the US Food and Drug Administration'sCardiovascular and Renal Drugs Advisory Committee has voted five to one against the approval of Bristol-Myers Squibb's Vanlev (omapatrilat), a new antihypertensive the company had once touted as a major contender in its pipeline. Analysts have previously forecast annual peak sales for the drug of $2 billion.

Though analysts and B-MS had discounted the blockbuster potential when the company withdrew its initial New Drug Application in April 2000, many had still expected Vanlev to be approved for a limited patient population. B-MS's stock was heavily damaged the day before the meeting, falling 7% on the news that FDA revewers had posted negative comments about Vanlev on the agency web site. B-MS shares fell only $0.30 on July 19, a "bloody market day" that saw the main US stock index off almost 5% at one point, reports the Marketletter's Washington DC correspondent.

Cardio-Renal panel members had no trouble accepting that Vanlev was a potentially powerful new blood pressure-lowering compound. But because it was the first in a new class - the vasopeptidase inhibitors - panelists wanted to set a higher bar for the drug's approval.