Below is a summary of updates to the
<font> BioMedReports.com FDA Calendar </font> , which includes a database of 288 entries as of 8/5/09. 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, ANDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage clinical trial results.
On 8/5/09, NeurogesX (NASDAQ:NGSX) announced that the FDA extended the PDUFA action date by three months to 11/16/09 for the Company’s pending new drug application (NDA) for Qutenza which is seeking approval to manage pain associated with post-herpetic neuralgia (PHN). The extension resulted from the Company's recent submission of data requested by the agency late in the review cycle, which the FDA has classified as a major NDA amendment. Submission of a major amendment within three months of the PDUFA date can trigger a three-month extension to the original review timeline. The information submitted in July includes a report from the Company’s recently completed C123 Study, which was performed at the request of the FDA.
On 7/24/09, NGSX announced preliminary results of Study C123, which evaluated Qutenza in patients with PHN following pre-treatment with an FDA approved topical anesthetic. Preliminary results of Study C123 showed the mean duration of patch application was 60.2 minutes, versus a target duration of Qutenza patch application of 60 minutes, and no patients removed the Qutenza patch prematurely. NGSX received approval on 5/21/09 to market Qutenza in the EU. Qutenza is a skin patch that is designed to locally deliver a high-concentration (8%) of the active substance capsaicin to provide sustained relief from peripheral nerve pain.
Based on positive interim Phase 3 clinical trial results reported on 12/4/08 for its HeartMate II Pump and discussions with the FDA, Thoratec (NASDAQ:THOR) previously announced (4/20/09) the submission of a PMA (Pre-Market Approval) supplement seeking to add the intended use of Destination Therapy (DT) for the HeartMate II LVAS (left ventricular assist system). The HeartMate II is a next generation heart assist device designed to provide long-term cardiac support for patients suffering from advanced stage heart failure. The device was approved for Bridge-to-Transplantation in the U.S. under the original PMA in April 2008, and the PMA supplement submission in April 2009 included data on a pivotal study cohort of 200 randomized patients, including two-year data on the first 167 patients enrolled.
In December 2008, Thoratec received approval from the FDA to end randomization in the trial, based on a pre-specified interim analysis of 67% of the first 200 patients that showed that patients implanted with the HeartMate II achieved statistically superior outcomes versus those in the control group who were implanted with the HeartMate XVE. On 8/5/09, THOR announced that the Company received what it considers to be routine questions from the FDA regarding its PMA Supplement for DT for the HeartMate II and expects to submit its response within a few days with marketing clearance from the Agency expected in early 2010 with the 3/31/10 date for this entry representing an estimate for the end of 1Q10 since medical device submissions do not have decision deadlines.
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