The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.
1.) Akermes (ALKS): Earlier this week, ALKS announced the completion of patient enrollment for the registration study of Vivitrol (naltrexone for extended-release injectable suspension) for the treatment of opiate dependence. ALKS expects topline results for the study during 4Q09 and plans to file a sNDA with the FDA during 2010 to expand the label of Vivitrol from its current indication in the treatment of alcohol dependence.
2.) Acorda Therapeutics (ACOR): 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). Acorda received a Refuse to File (RTF) letter for the Fampridine-SR NDA in late March, citing the need to correct "format issues" and requesting additional supporting information before the NDA could be accepted for review. Based on subsequent discussions with the FDA, Acorda has resubmitted the Fampridine-SR NDA and believes that all of the Agency's comments related to the RTF have been addressed. 6/23/09 is the date for FDA to accept this filing and 2/23/10 would be the PDUFA decision date for a standard, 10-month review of the NDA if accepted.
3.) GTx Inc. (GTXI): On 4/22/09, GTXI announced that data from its Phase 3 clinical trial evaluating toremifene 80 mg for the prevention of fractures in men with prostate cancer on androgen deprivation therapy will be the subject of an oral podium presentation at the 2009 Annual Meeting of the American Urological Association being held in Chicago April 25-30.
GTXI is awaiting a FDA decision for its toremifene 80 mg NDA (standard 10-month review) for bone loss due to prostate cancer. Toremifene 80 mg is an oral selective estrogen receptor modulator which GTx seeks to market for the prevention of bone fractures in men with prostate cancer on androgen deprivation therapy (ADT). ADT is primary treatment for advanced prostate cancer. In the United States, approximately 700,000 men with prostate cancer are being treated with ADT and an estimated 100,000 initiate ADT each year.
Disclosure: No positions.
