2006 FDA Advisory Committee Recommendations

2006 FDA Advisory Committee Recommendations
The following chart lists recent committee actions. For a list of pending NDAs/BLAs that have been recommended by an advisory committee, visit www.PharmaceuticalApprovals.com.
Product	Sponsor	Committee Decision	Meeting	FDA Action
Abraxane Paclitaxel, nanoparticle albumin-bound	Abraxis	Committee voted 13-1 in favor of requiring Abraxis to conduct an adequate, well-controlled, randomized trial of Abraxane in order to receive an adjuvant breast cancer claim	9/7/2006
Alli ^a orlistat	GlaxoSmithKline	Committee voted 11-3 that the 60 mg version of Roche's Xenical should be approved for OTC use; panel requested larger actual use study	1/23/2006	Approved 2/7/2007
Celebrex ^aCelecoxib	Pfizer	Committee voted 15-1 that the risk/benefit ratio of the COX-2 inhibitor in juvenile rheumatoid arthritis warrants approval; panel voted 8 to 7, with one abstention, that existing data do not establish safety for chronic celecoxib use	12/4/2006	Approved 12/15/2006
Cellegesic Nitroglycerin 0.4%, ointment	Cellegy	Committee split on whether ointment should be approved for anal fissure pain based on available data; panelists voting in favor of approvable said additional evidence could not be gained from further studies	4/25/2006	Approvable 7/7/2006; FDA requested additional efficacy trial
Cubicin ^a Daptomycin	Cubist	Committee voted unanimously that data are sufficient to support approval of Cubicin in treatment of S. aureus bacteremia; panel voted 5-4 that subgroup data from a pivotal trial provided substantial evidence of safety and efficacy in infective endocarditis	3/6/2006	Approved 5/25/2006 for treatment of S. aureus infections including right-sided endocarditis following a 3/24/2006 approvable letter
Exelon ^aRivastigmine	Novartis	Committee voted unanimously in support of use of Exelon in treatment of mild-to-moderate dementia associated with Parkinson's disease dementia (PDD); panel also voted unanimously that PDD is a distinct clinical entity from Alzheimer's disease	5/17/2006	Approved 6/27/2006
Factive ^aGemifloxacin	Oscient	Committee voted 11-2 that safety and efficacy data do not support sNDA for five-day treatment of sinusitis; panel recommended sponsor conduct placebo-controlled superiority studies to confirm efficacy	9/12/2006
Fragmin ^aDalteparin	Pfizer	Committee unanimously recommended approval for treatment and prevention of venous thromboembolism in cancer patients	9/12/2006	Approvable 3/15/2006
Gardasil Quadrivalent human papillomavirus types 6, 11, 16, 18, recombinant vaccine	Merck	Committee voted unanimously in favor of safety and efficacy of the vaccine; panel stressed that labeling should emphasize need for cervical cancer screening, even in women who receive the vaccine	5/18/2006	Approved 6/8/2006
Gemzar ^aGemcitabine	Lilly	Committee voted 9-2, with one abstention, against recommending approval of recurrent ovarian cancer claim; panel deemed progression-free survival data insufficient and said pivotal trial was poorly designed	3/13/2006	Approved 7/14/2006; FDA said decision reflects willingness to accept delay in progression as clinical benefit
Genasense ^bOblimersen	Genta	Committee voted 7-3 that sponsor's Phase III trial did not show substantial evidence of clinical benefit	9/6/2006	Not approvable 12/2006; Firm will appeal FDA action during 1Q 2007
Gestiva 17 alpha-hydroxyprogesterone caproate	Adeza	Panel voted 12-9 that there was sufficient evidence that Gestiva prevents preterm birth prior to 35 weeks; committee voted 13-8 that Adeza's safety package is adequate to support approval provided additional studies are done to further characterize a relationship between the agent and miscarriages and still births	8/29/2006	Approvable 10/2006; FDA requests additional animal study and "certain other conditions" before approval
Hemopure Hemoglobin glutamer	Biopure	Committee voted 11-8, with one abstention, that the potential benefits of the Naval Medical Research Center's proposed Phase III study of prehospitalization resuscitation in severe hemorrhagic shock do not outweigh the potential risks	12/14/2006
Ketek Telithromycin	Sanofi-Aventis	Committee voted 17-2 that risks outweigh the benefits of Ketek use for treatment of acute exacerbation of chronic bronchitis and acute bacterial sinusitis; panel voted 16-3 that the ketolide antibiotic should retain its community acquired pneumonia indication	12/14-15/2006	AECB and ABS indications dropped from labeling 2/14/2007
Levothyroxine	Multiple sponsors	Committtee voted 23-2, with one abstention, that a 10% loss in potency is clinically significant; panel also voted 24-1, with one abstention, that potency specifications should be narrowed	10/4/2006
Nabi-HB ^aHepatitis B immune globulin (human)	Nabi Biopharma	Committee voted 9-2, with three abstentions, in favor of approval for prevention of recurrence of hepatitis B after liver transplant in HBV-positive liver transplant patients	7/13/2006
Sparlon ^aModafinil	Cephalon	Committee voted 12-1 that current safety data were insufficient for use in children with attention deficit/hyperactivity disorder, but voted unanimously in favor of efficacy in ADHD; panel said Cephalon should conduct a 3,000-patient safety study to rule out risk of serious skin infections	3/23/2006	Not approvable 8/9/2006; Cephalon announced it was halting development of Sparlon
Sprycel ^bDasatinib	Bristol-Myers Squibb	Committee voted unanimously in favor of accelerated approval in chronic, accelerated and blast-phase imatinib-resistant patients and 13-0, with one abstention, for all three phases of chronic myeloid leukemia in imatinib-refractory patients; panel voted 12-1, with one abstention, in favor of full approval for treatment of imatinib resistant Ph+ acute lymphoblastic leukemia patients	6/2/2006	Approved 6/28/2006 for all three indications
Trasylol Aprotinin	Bayer	Committee voted 18-0, with one abstention, that the totality of clinical data support safety and efficacy in certain CABG patients; panel supported Bayer's proposal to modify indication to include language on use in patients undergoing cardiopulmonary bypass in the course of CABG surgery at increased risk for blood loss and blood transfusion	9/21/2006	Indication narrowed 12/15/2006 to patients at an increased risk of blood loss and blood transfusion in association with cardiopulmonary bypass during CABG
Tysabri Natalizumab	Biogen Idec/Elan	Committee unanimously recommended multiple sclerosis agent should be returned to market, but narrow majority (7-5) voted in favor of approval for patients with MS who have not tried any of the other available first-line therapies. Panel said sponsor should not be required to conduct any studies prior to returning the product to market; group also recommended that Tysabri not be used in combination with other MS treatments and that sponsors' proposed patient/physician registry should be mandatory	3/7-8/2006	Approved for market re-entry 6/5/2006 with TOUCH risk management program; revised indication allows for both first- and second-line use
^a Submission is for a new use or new formulation of product that sponsor already markets ^b New molecular entity or combination product with NME as component