Below is a summary of updates to the BioMedReports.com database of 233 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 deadline dates.
The entries are updated on a daily basis as new information becomes available with a total of 101 entries through today. The FDA Calendar includes the following information: company name, ticker, decision date, and description.
The Clinical Trial Calendar includes 132 entries as of today and 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.
1.) Takeda Pharma (TKPHY.PK) + Pharmaceutical Product Development (PPDI): Alogliptin (SYR-322) NDA for Type 2 Diabetes. PPDI receives $25M if approved from Takeda Pharma. Update from the FDA suggests more clinical data will be required for the alogliptin NDA, even though the application was filed prior to issuance of the agency's December 2008 guidance on new Type 2 diabetes treatments.
The FDA will apply the new guidelines when reviewing the alogliptin NDA, and the agency does not believe that the amount of existing alogliptin clinical data is sufficient to meet certain statistical requirements in the new guidance. The agency is open to discussions regarding the design of additional cardiovascular (CV) studies with alogliptin. Alogliptin's PDUFA date of 6/26/09 remains unchanged.
Last December, the FDA issued "Guidance for Industry: Diabetes Mellitus -- Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes". In October 2008, Takeda received notification from the FDA that it was unable to complete its review of the alogliptin NDA by the original PDUFA date of 10/27/08 due to internal resource constraints. The FDA did not raise any issues with the data in the alogliptin NDA at that time.
2.) Novo Nordisk (NVO) is also awaiting a FDA decision for a new diabetes drug, Victoza (liraglutide), which is a long-acting analog of glucagon-like peptide-I or GLP-I). The NDA for Victoza will be reviewed as part of a April 2-3 FDA Advisory Panel Meeting (the original PDUFA date was 3/23/09).
3.) Forest Labs (FRX) Spain's Almirall (ALM.MC) announced a delay today of the NDA for its lung treatment aclidinium bromide in the U.S. with partner Forest Labs (FRX) following a meeting with the FDA. Almirall and FRX had planned to submit the drug to treat chronic obstructive pulmonary disease (COPD) in late 2009 - early 2010.
After discussions with the FDA, Almirall determined that additional clinical studies will be conducted on aclidinium bromide for COPD. The timeline for further clinical trials and a potential FDA filing for approval are not yet clarified. Further tests will try higher and more frequent doses of aclidinium bromide after the lung drug suffered a major setback last year when Phase 3 trials showed it was less effective than believed as a once-daily treatment for COPD.
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