Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the
FDA and Clinical Trial Calendars. The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.
AstraZeneca (NYSE:AZN): On 5/11/09, AZN announced top line results from the phase III trial, PLATO (A Study of Platelet Inhibition and Patient Outcomes), which demonstrate that BRILINTA (ticagrelor), the investigational oral antiplatelet treatment for acute coronary syndromes (ACS), has achieved a statistically significant primary efficacy endpoint versus Plavix (clopidogrel), in the prevention of cardiovascular (CV) events in patients with ACS. The primary efficacy measure was time to first occurrence of any event from the composite of myocardial infarction, stroke, and CV death.
In PLATO, the overall safety profile for BRILINTA was in line with the safety data observed in the phase II studies. Given the size of the PLATO trial, further analysis of the entire database, secondary variables, and subgroups is ongoing. AstraZeneca and the PLATO Executive Committee's aim is to submit the PLATO data to a peer-reviewed medical journal and present at the European Society of Cardiology annual meeting in August 2009 and submit for regulatory approvals during 4Q09.
Molecular Insight Pharma (NASDAQ:MIPI): In March 2009, MIPI provided positive detailed data on Phase 2 clinical trial for Zemiva. In the trial, the combination of Zemiva imaging with initial clinical diagnostic information resulted in improved sensitivity for detecting ischemia (85%) that was statistically significant (p < 0.0001), when compared to the sensitivity of the initial clinical diagnosis alone (52%). Zemiva enables rapid detection of acute cardiac ischemia in the emergency room setting. The FDA has indicated that a single Phase 3 trial, with robust results, would be sufficient to support Zemiva's approval.
