Bristol-Myers Squibb Vanlev
This article was originally published in Pharmaceutical Approvals Monthly
Omapatrilat reduced relative risk of death or hospitalization from worsening heart failure when compared to lisinopril in two trials presented at the 49th annual American College of Cardiology meeting. The studies compared Vanlev to AstraZeneca's ACE-inhibitor Zestril (lisinopril) to assess the effects of vasopeptide inhibition on morbidity and mortality in heart failure. In a 52-week trial, 340 patients were randomized to 20 mg omapatrilat and 329 patients to 20 mg lisinopril. In a 24-week trial, 289 patients were randomized to 40 mg omapatrilat and 284 patients to 20 mg lisinopril. Relative risk of death or hospitalization due to worsening heart failure was 0.78 for 20 mg omapatrilat (95% CI with a range from 0.56 to 1.11) and 0.53 for the 40 mg dose (95% CI, range: 0.27 to 1.02). In a pooled analysis of both studies, Vanlev showed a statistically significant reduction of 0.72 for the relative risk of both endpoints (95% CI, range: 0.53 to 0.97). Investigators said both drugs were well tolerated, and the overall incidence of serious cardiovascular adverse events, renal dysfunction, and marked elevations in creatinine was lower with Vanlev than with Zestril. Hypotension was more common in the omapatrilat group (11% vs. 6.5% for lisinopril), and syncope was more common for lisinopril patients (5.1% vs. 1.4% for omapatrilat). Vanlev is scheduled for FDA advisory committee review May 1
You may also be interested in...
The FDA has published fresh guidance taking a tougher stance on sponsor reasons for needing more time to respond to complete response letters.
Stada has named Yann Brun to become the group’s new head of global development, portfolio, regulatory and business development, replacing Robert Knerr. The move is the latest in a string of key appointments at Stada as the firm builds on a series of acquisitions and deals.
A letter from more than 60 leading public health and medical ethics experts has been sent to Pfizer's CEO Albert Bourla.