Below is a summary of updates to the
BioMedReports.com FDA Calendar, which includes a database of over 200 entries. 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 pivotal Phase 3 clinical trial results which are designed to support a filing for FDA approval.
On 6/25/09, H. Lundbeck (CPH:LUN) (PINK:HLUKY) announced that the Company has received a Complete Response Letter (CRL) from the FDA for Serdolect (sertindole) for the treatment of schizophrenia. The Agency's CRL includes a request for additional data to best understand the appropriate patient population for which Serdolect could be made available, and the Company is currently evaluating the information in order to resolve the outstanding questions and discuss the next steps required to bring Serdolect safely to the U.S. market.
In the coming months, the Company expects to address the CRL and will work with the FDA to expedite completion of its review. On 4/7/09, a FDA Advisory Panel voted 8-2 (three panelists abstained from the vote) in favor of FDA approval for Serdolect among certain patients (such as those who do not respond to other treatments) despite concerns about heart-related risks. The Company proposed that Serdolect reduced suicide attempts, which is a major risk for patients with schizophrenia. However, the panel rejected this notion in a 12-1 vote based on a lack of convincing evidence to support the claim. Serdolect received marketing approval for the treatment of schizophrenia from the European Commission on 12/20/05 and is available in 40 countries worldwide.
European regulators have recommended approval of Onglyza (saxagliptin) a new diabetes drug from AstraZeneca (NYSE: AZN) and Bristol-Myers (NYSE: BMY), which clears the way for its launch in the coming months as such recommendations are typically endorsed by the European Commission within two or three months. The two companies announced that their drug won a positive opinion for type 2 diabetes as an as add-on therapy along with older medications such as metformin, thiazolidinedione or sulphonylurea. On 4/1/09, the Endocrinologic and Metabolic Drugs Advisory Committee for the FDA voted 10 to 2 that the companies' data ruled out the risk that the drug hastens heart attack, stroke and other problems with a final decision by the Agency expected by late July.
On 6/25/09, Insmed (NASDAQ:INSM) announced results from a Phase II clinical trial evaluating IPLEX (mecasermin rinfabate) in patients with myotonic muscular dystrophy (MMD).
