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.
On 5/28/09, Incyte Corp. (NASDAQ: INCY) announced that based on recent input from the FDA regarding the Company's request for a Special Protocol Assessment (SPA) for INCB18424 for patients with primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF) and post-essential thrombocythemia myelofibrosis (PET-MF), it is clear that the most appropriate single primary endpoint for Incyte's U.S. Phase 3 trial is the proportion of treated patients achieving a 35% reduction in spleen volume as compared to patients receiving placebo.
The Company provided guidance that included a modest delay in starting the Phase 3 study, and INCY expects to complete the trial in a time frame that will allow for filing a New Drug Application in late 2010 or early 2011 assuming positive results are achieved (which is still in-line with previous guidance). Incyte expects to begin enrollment of COMFORT-I (COntrolled MyeloFibrosis Study with ORal JAK Inhibitor Treatment) in August 2009. The Phase 3 European trial, COMFORT-II, is scheduled to begin enrollment in June 2009.
Johnson & Johnson (NYSE: JNJ) and Bayer (PINK: BAYRY): Xarelto (Rivaroxaban) NDA for treatment of deep vein thrombosis (DVT) + pulmonary embolism (PE). On 3/19/09, FDA Advisory Panel of outside advisers voted 15 to 2 in favor of Xarelto, but cited lingering concerns about possible liver damage and bleeding. On 5/28/09, the FDA issued a complete response letter (CRL). The FDA has not requested that any new clinical or non-clinical studies be conducted to evaluate the drug, according to the companies.
"Together with our development partner (JNJ), we are evaluating the letter and we will promptly address the FDA's questions," Bayer said, declining to specify what type of information was requested. The drug is already approved in Europe to prevent blood clots after major orthopedic surgery, and the two companies are also seeking clearance for the potential blockbuster in the United States, its largest market.
