Below is a summary of updates to the
BioMedReports.com FDA Calendar, which includes a database of 289 entries as of 7/30/09. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of BioMedReports.com, the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage clinical trial results.
On 7/30/09, Anadys Pharma (NASDAQ: ) announced finalization of the protocol for the Company's Phase 2 trial of ANA598 in combination with pegylated interferon-alpha and ribavirin in hepatitis C patients. Allowance of the protocol has been received from the FDA and patient dosing is expected to commence within the next several weeks. In the Phase 2 study, naive genotype 1 patients will receive ANA598 or placebo in combination with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin, USP) (a current standard of care, or SOC) for 12 weeks at dose levels of 200 mg or 400 mg twice daily (bid), each with a loading dose of 800 mg bid on day one. After week 12, patients will continue to receive SOC. Patients who achieve undetectable levels of virus at weeks 4 and 12 will be randomized to stop all treatment at week 24 or 48.
The primary endpoint of the study is the proportion of patients with undetectable virus at week 12 (defined as complete Early Virological Response, or cEVR). Additional endpoints include safety and tolerability as well as the proportion of patients with undetectable virus at week 4 (defined as Rapid Virological Response, or RVR), weeks 24 and 48, and 24 weeks after stopping all treatment (defined as Sustained Virological Response, or SVR). Ninety patients are planned to be enrolled in this study - thirty patients receiving ANA598 and fifteen receiving placebo at each dose level. Anadys expects to receive 28-day safety and response (RVR) data from the 200 mg dose level by year-end 2009 and additional on-treatment safety and response data from both cohorts during the first two quarters of 2010.
On 7/30/09, Schering-Plough (NYSE: ), which is being acquired by Merck (NYSE: ), announced that the FDA Psychopharmacologic Drugs Advisory Committee voted unanimously in favor of Saphris (asenapine) sublingual tablets as effective and safe for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults and in favor of youth in acute treatment of schizophrenia in adults. The panel voted in favor of Saphris as effective (by counts of 12/0/0 and 10/2/0, yes/no/abstain) and safe (12/0/0 and 10/0/2) for the bipolar I disorder and schizophrenia indications, respectively.
In addition, the committee voted on the overall balance of safety and efficacy by counts of 12/0/0 and 9/1/2 for the bipolar I disorder and schizophrenia indications, respectively. In Europe, a Marketing Authorization Application (MAA) for asenapine, under the brand name Sycrest, is currently under review by the European Medicines Agency (EMEA) for the treatment of schizophrenia and manic episodes associated with bipolar I disorder. On 2/20/09, SGP resubmitted the NDA in response to the FDA's complete response letter in January 2009.
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