Bristol-Myers Squibb Delays Vanlev Application Pending Additional Studies

On April 19, Bristol-Myers Squibb Co. (BMS; Princeton, NJ) voluntarily withdrew its current New Drug Application (NDA) for its Vanlev (omapatrilat) antihypertensive agent. BMS took this drastic action in response to questions raised recently by the U.S. Food and Drug Administration regarding incidence and severity of angioedema, an infrequent side effect reported within the NDA database. Angioedema is a localized swelling that generally affects the face, throat, lips, or tongue that can be triggered by food and commonly used drugs such as ACE- inhibitors, nonsteroidal anti-inflammatory agents, and some antibiotics.

BMS expects to resubmit its application early next year. It is working with FDA to identify additional data needed to resolve the agency's questions. Simultaneously, prospective controlled clinical studies in patients with hypertension and heart failure will continue. Regulatory filing activities outside the U.S. for Vanlev are proceeding as planned.

Vanlev, the most clinically developed member of the vasopeptidase inhibitor class of cardiovascular compounds, simultaneously inhibits two key enzymes—angiotensin-converting enzyme (ACE), and neutral endopeptidase (NEP)—which regulate systolic and diastolic blood pressure, respectively.

In January 2000, FDA provided a priority review for Vanlev, a status the agency grants for drugs considered to be a significant therapeutic advance under the Prescription Drug User Fee Act (PDUFA). Vanlev became the first antihypertensive to receive a priority review under this system.

Hypertension, or high blood pressure, affects more than 600 million people worldwide. Three of four people with high blood pressure in the U.S. are not at or below the recommended target goal of lower than 140/90 mmHg and remain at higher risk for heart attack, stroke, heart failure, and kidney disease.

What will be the impact of Vanlev's temporary withdrawal? See related analysis by Datamonitor.

For more information, contact Tim Cost of Bristol-Myers Sqibb at 212-546-4103.

Edited by Angelo DePalma