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.
Genzyme (NASDAQ:GENZ) and Isis Pharma (NASDAQ:ISIS) announced on 5/20/09 that the Phase 3 clinical trial of mipomersen in patients with homozygous familial hypercholesterolemia (hoFH) met its primary endpoint, with a 25% reduction in LDL cholesterol after 26 weeks of treatment compared to a 3% placebo reduction (p<0.001). This study also met each of its three secondary endpoints of reduction in levels of apolipoprotein B, total cholesterol, and non-HDL cholesterol (all p<0.001). Data from this phase 3 study of mipomersen in patients with hoFH will form the basis of Genzyme's initial regulatory filing for marketing approval, which is expected to occur during 2H10.
Although the patients were on maximally tolerated statins and other lipid-lowering therapies, their average LDL-C at baseline was greater than 400 mg/dL. The reductions observed in the study were in addition to those achieved with the patients' existing therapeutic regimen. Full data from the study will be presented at a future medical meeting. Consistent with previous studies evaluating mipomersen, the most commonly observed adverse events were injection site reactions, flu-like symptoms, and elevations in liver enzymes. Of the 34 patients treated with mipomersen, 28 completed the study. One patient discontinued due to elevations in liver enzymes.
On 5/20/09, Dainippon Sumitomo Pharma (TYO:4506) (PINK:DNPUF) announced positive results from its first Phase 3 clinical trial for lurasidone, which is under global clinical development for the treatment of patients with schizophrenia. In this six-week, double-blind, placebo-controlled trial, lurasidone 80 mg/day was significantly more effective than placebo for the treatment of acute schizophrenia. In addition, lurasidone was well-tolerated and had a relatively low discontinuation rate. The Company intends to file a New Drug Application (NDA) for FDA approval upon completion of its Phase 3 clinical development program.
