Below is a summary of updates to the
BioMedReports.com FDA Calendar, which includes a database of 290 entries as of 8/4/09. 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 7/1/09, Acorda Therapeutics (NASDAQ:
) announced an exclusive deal with Biogen Idec (NASDAQ:BIIB) to develop and commercialize Fampridine-SR in markets outside the U.S. while Acorda will continue to develop and commercialize Fampridine-SR in the U.S. Acorda will receive an upfront payment of $110 million and additional payments of up to $400 million based on the successful achievement of future regulatory and sales milestones along with tiered, double-digit royalty payments on ex-US sales. The FDA is currently reviewing a New Drug Application (NDA) for Fampridine-SR with a Priority Review (six-month) designation and a PDUFA action date during mid-4Q09 for a possible FDA decision.
On 4/23/09, ACOR announced the resubmission of its NDA for Fampridine-SR to the FDA as a new therapy being developed to improve walking ability in people with multiple sclerosis (MS) in response to a Refuse to File letter for the NDA on 3/30/09. On 5/6/09, the FDA accepted the NDA with a priority review designation and PDUFA decision date of 10/22/09 as there are currently no FDA approved treatments to improve the walking ability of people with MS. On 8/4/09, ACOR announced that a Peripheral and Central Nervous System Drugs FDA Advisory Committee meeting will be held to review Fampridine-SR, with the date to be announced. ACOR also provided an update of adverse events (AE) for its three key MS studies with the only new AE being MS relapse (at 5.3% for the Fampridine-SR treated group vs. 3.8% for placebo). The imbalance for this AE was due to worsening of MS symptoms occurring after discontinuation of the drug.
On 8/4/09, DOR BioPharma (DORB.OB) announced that the FDA granted Orphan Drug Designation to Oral BDP (beclomethasone 17,21-dipropionate or orBec) for the treatment of gastrointestinal symptoms associated with chronic Graft-versus-Host disease (cGVHD) in patients who have undergone allogeneic hematopoietic cell transplantation. orBec is a highly potent, topically active corticosteroid that has a local effect on inflamed tissue.
