New Drug Application Withdrawn
Bristol-Myers Squibb Pulls Vanlev
PRINCETON, NJ- Vanlev, the first antihypertensive drug to receive priority review by the Food and Drug Administration (FDA), has been withdrawn from the approval process. Bristol-Myers Squibb voluntarily pulled the application due to questions raised by the FDA regarding a potential side effect. Though infrequent, the possibility of angioedema, a localized swelling affecting the face, throat, lips, or tongue, has been cited in some cases. Vanlev was designed to inhibit simultaneously two key enzymes, the angiotensin-converting enzyme (ACE) and neutral endopeptidase (NEP) that regulate blood pressure. Studies have shown that the drug significantly reduces both systolic and diastolic blood pressure. The company hopes to resubmit the application early next year after new data has been compiled.
