Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of 260 entries as of 7/15/09. I originally created this calendar 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 clinical trial results.
On 7/15/09, the Oncologic Drugs FDA Advisory Committee of cancer drug experts voted 14-1 against approval of Johnson & Johnson's (NYSE:JNJ) Yondelis (trabectedin) NDA, which seeks approval in combination with Doxil (doxorubicin) for the treatment of relapsed ovarian cancer in women. The expected PDUFA action date is 9/20/09 for a possible final FDA decision on this NDA. Final overall survival data for Yondelis is expected within about 18-24 months (early to mid 2011).
The FDA Advisory Panel members were willing to reconsider the drug once final data is available and safety concerns were raised for the drug, including pulmonary embolism (blood clots in the lung), cardiac adverse events, and liver toxicity.
On 7/15/09, Cadence Pharma (NASDAQ:CADX) announced that its New Drug Application (NDA) for Acetavance (intravenous acetaminophen), its investigational product candidate for the treatment of acute pain and fever in adults and children, has been accepted for filing by the FDA and designated for a priority (six-month) review. The FDA has issued a PDUFA action date for the NDA of 11/13/09 for a possible decision by the Agency. The Company's 505(b)(2) NDA for Acetavance includes data from one pivotal clinical trial for the treatment of acute pain in patients following orthopedic surgery and one pivotal clinical trial for the treatment of endotoxin-induced fever.
The NDA is also supported by data from a total of nine placebo-controlled clinical trials, four active-controlled clinical trials, and seven other safety or pharmacokinetic clinical trials. The submission includes safety data from over 1,400 patients who received Acetavance in clinical trials, including 350 pediatric patients, from premature neonates to adolescents, and data from safety reports that collectively represent more than 53 million patient exposures to intravenous acetaminophen in countries outside of the U.S.
On 7/15/09, Watson Pharma (NYSE:WPI) announced the filing of an Abbreviated New Drug Application (ANDA) with the FDA seeking approval to market its trospium chloride extended-release 60 mg capsules prior to the patent expiration of the drug.Watson's trospium chloride extended-release capsules are the generic version of Allergan's (NYSE:AGN) Sanctura XR product (12-month U.S. sales of about $42 million thru 3/31/09), which is indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency.
AGN filed suit against Watson on 7/13/09 seeking to prevent generic competition prior to expiration of U.S. patent number 7,410,978, resulting in a stay of final FDA approval of Watson's ANDA for up to 30 months or until final resolution of the matter before the court, whichever occurs sooner. Watson believes it may be first to file an ANDA for generic trospium extended-release capsules.
On 7/15/09, Targacept (NASDAQ:TRGT) announced positive top-line results from a double blind, placebo controlled, flexible dose Phase 2b clinical trial of TC-5214 as an augmentation (add-on) treatment for major depressive disorder (MDD) in subjects who did not respond adequately to first-line treatment with citalopram (Celexa) alone. The result on the primary outcome measure for the trial, mean change between treatment (TC-5214 + citalopram) and placebo (placebo + citalopram) from baseline on the Hamilton Rating Scale for Depression-17, or HAM-D, was highly statistically significant in favor of TC-5214 on an intent to treat basis.
In addition, TC-5214 exhibited a favorable tolerability profile in the trial. The most frequent adverse events were headache, dizziness and constipation. TRGT plans to present detailed results from the Phase 2b trial of TC-5214 in October 2009 and expects Phase 3 clinical development to be initiated during 2Q10 following planned discussions with FDA and production of clinical trial material.
Disclosure: No positions.