Below is a summary of updates to the
BioMedReports.com FDA Calendar, which includes a database of 294 entries as of 8/6/09. 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 8/6/09 , Orexo AB (STO: ) announced that its partner, UK-based international specialty pharma ProStrakan Group plc (LSE:PSK) (PKNGF.PK), submitted a New Drug Application (NDA) for Abstral to the FDA. The filing of Abstral will generate a milestone payment to Orexo as part of the agreement with ProStrakan for North America that in total can give US$27 million in certain regulatory and sales milestone payments In addition to royalties on product sales.
Abstral is a fast-dissolving tablet for sublingual administration of fentanyl, intended for the management of breakthrough cancer pain in patients who are already receiving opioid analgesics. It is based on Orexo's unique and patented sublingual tablet technology in which a rapidly dissolving tablet is placed under the tongue and the active substance is absorbed by the mucous membrane. Currently Abstral is sold in Sweden, UK, Germany and France.
On 7/3/09, Novo Nordisk (NYSE: ) announced European Commission marketing authorization for Victoza (liraglutide) in the treatment of type 2 diabetes in adults. NVO will launch Victoza in Britain, Germany, and Denmark this summer and in other European markets during the remainder of 2009 and in 2010. Victoza is regarded as the most important compound in Novo's pipeline and a key FDA decision is still pending. The original PDUFA action date for the Company's pending Victoza NDA for type 2 diabetes was 3/23/09, but a FDA decision is still pending.
Victoza is used once-daily via subcutaneous injection, and the drug is a synthetic glucagon-like peptide-1 (GLP-1) that works by stimulating insulin release when glucose levels become high. On 4/2/09, an FDA Advisory Panel stated liraglutide does not appear to carry heart risks, though serious questions remain about its possible links to tumors.
