B-MS to delay Vanlev refiling with FDA

Bristol-Myers Squibb has announced that it will continue the OCTAVEstudy of its vasopeptidase inhibitor Vanlev (omapatrilat) hypertension study, and now hopes to refile its New Drug Application for the drug in the USA in the late summer or early fall. The company had originally forecast submitting the NDA to the US Food and Drug Administration after an interim analysis of the data from the study.

OCTAVE is comparing the efficacy and safety in hypertension of omapatrilat and Merck & Co's ACE inhibitor Vasotec (enalapril) over 24 weeks of treatment. The company has chosen the option of keeping the study blinded until all patients have completed their 24 weeks of therapy, rather than unblinding the data early.

B-MS withdrew its original NDA for omapatrilat in the USA last year after initial signs that further data would be required to secure approval (Marketletters passim). The drug has been tipped as a blockbuster, with peak sales well in excess of $1 billion.