Meeting Details:

On May 23, 2012, the Committee will discuss supplemental new drug application (sNDA) 202439/S-002 XARELTO (rivaroxaban), submitted by Janssen Pharmaceuticals, Inc. to reduce the risk of thrombotic cardiovascular events in patients with acute coronary syndrome (ACS) [ST elevation myocardial infarction (STEMI), non-ST elevation myocardial infarction (NSTEMI), or unstable angina (UA)] in combination with aspirin alone or with aspirin plus clopidogrel or ticlopidine.

Meeting Details:

On May 24, 2012, the committee will discuss new drug application (NDA) 202737 for tafamidis meglumine capsules, proposed trade name VYNDAQEL, submitted by FoldRx Pharmaceuticals, Inc. a subsidiary of Pfizer, Inc. The proposed indication is for the treatment of transthyretin (TTR) familial amyloid polyneuropathy.

Meeting Details:

On May 24, 2012, the committee will discuss current knowledge about the safety and effectiveness of the AMPLATZER ASO Device & Gore HELEX ASD Occluder as transcatheter Atrial Septal Defect (ASD) occluders used for the closure of secundum atrial septal defects. The AMPLATZER Septal Occluder (ASO) Device was the first device introduced to the US market in 2001 followed by the Gore HELEX device in 2006. With more widespread use of these devices, more information has become available regarding adverse events. These events range from rare life-threatening events to more common events that are perceived to have less severe clinical sequelae. Many of these events were evident in the premarket studies; however, rare events such as erosion were not seen. The purpose of discussion of these events is: (1) to discuss the significance of these events in the overall context of the disease and existing treatment options; (2) to discuss whether additional measures should be taken to improve protection of the public health (e.g., additional study and/or data analyses, labeling changes); and (3) to communicate to patients and physicians what is and is not known about device treatment options.

Meeting Details:

The purpose of the meeting is to provide a forum to discuss the available data on the use of analgesics in the treatment of CNCP, beginning with a discussion of the underlying mechanisms of chronic pain and the epidemiology of chronic pain in the United States. Next, data on the efficacy of opioids and other analgesics in the treatment of chronic pain from a variety of sources will be reviewed. Those sources will include randomized controlled trials, epidemiological studies, case series and other types of studies. Patient and clinician perspectives on the pharmaceutical treatment of CNCP will be presented by people living with chronic pain and those who treat or care for patients with chronic pain. Finally, a general assessment of the available data and discussion of future research needs and next steps will be used to inform future actions that can help guide appropriate therapy for patients with CNCP.

Meeting Details:

On June 13, 2012, the committee will discuss, make recommendations and vote on information related to the premarket approval application for the Edwards SAPIEN Transcatheter Heart Valve sponsored by Edwards Lifesciences. The Edwards SAPIEN Transcatheter Heart Valve is indicated for use in patients with symptomatic severe aortic stenosis who have high operative risk.

Meeting Details:

On June 20, 2012, during the morning session, the committee will discuss new drug application (NDA) 203213, with the established name semuloparin sodium injection, application submitted by sanofi-aventis U.S. LLC. The proposed indication (use) for this product is for the prophylaxis of venous thromboembolism (VTE) in patients receiving chemotherapy for locally advanced or metastatic pancreatic or lung cancer or for locally advanced or metastatic solid tumors with a VTE risk score = 3. During the afternoon session, the committee will discuss NDA 202714, with the proposed trade name Kyprolis (carfilzomib) for injection, application submitted by Onyx Pharmaceuticals, Inc. The proposed indication (use) for this product is for the treatment of patients with relapsed and refractory (recurring and/or not responsive to other treatments) multiple myeloma who have received at least 2 prior lines of therapy that included a proteasome inhibitor and an immunomodulatory agent.

Meeting Details:

On June 21, 2012, the committee will discuss, make recommendations, and vote on information related to the premarket approval application, sponsored by Dune Medical Devices, Inc., for the MarginProbe System, that utilizes electromagnetic waves to characterize human tissue in real time and provides intraoperative information on the malignancy of the surface of the ex vivo lumpectomy specimen.

Meeting Details:

The committee will discuss new drug application (NDA) 203-100, for a fixeddose combination tablet of elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate, submitted by Gilead Sciences, Inc. The application proposes an indication for the treatment of HIV-1 infection in adults who are antiretroviral naïve or have no known substitutions associated with resistance to the individual components.

Meeting Details:

The Food and Drug Administration (FDA) is announcing a 1-day public hearing to obtain input on recently issued draft guidances relating to the development of biosimilar products (draft guidances). These draft guidances were issued by FDA as part of the implementation of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). The BPCI Act establishes an abbreviated licensure pathway for biological products that are demonstrated to be biosimilar to, or interchangeable with, a reference product. FDA will consider the information it obtains from the public hearing in the finalization of these guidances. In addition, FDA is soliciting public input regarding topics for future policies regarding biosimilars.

Meeting Details:

On May 10 and 11, 2012, the committee will discuss general issues related to medical devices intended for obese patients. The committee will provide recommendations regarding trial design for clinical studies to evaluate the safety and effectiveness of weight loss devices placed either endoscopically (balloons and suture devices) or laparoscopically (bands, space-occupying devices, etc.) and contrast those to surgery. Additional discussion will include issues pertaining to clinically meaningful weight loss, when the primary endpoint should be measured, length of patient followup, and how much risk is acceptable for a potentially small amount of weight loss.

Meeting Details:

The committee will discuss an efficacy supplement for new drug application (NDA) 21-572, TRUVADA (emtricitabine/tenofovir disoproxil fumarate) Tablet, submitted by Gilead Sciences, Inc. The supplemental application proposes an indication for Pre-Exposure Prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection.

Meeting Details:

The committee will discuss the safety and efficacy of new drug application (NDA) 22–529 (lorcaserin hydrochloride) tablets, manufactured by Arena Pharmaceuticals, Inc., as an adjunct to diet and exercise for weight management in patients with a body mass index (BMI) equal to or greater than 30 kilograms (kg) per square meter or a BMI equal to or greater than 27 kg per square meter if accompanied by weight-related comorbidities.

Meeting Details:

The committee will discuss new drug application (NDA) 203214, tofacitinib tablets, Pfizer Inc., for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs.

Meeting Details:

The committee will discuss supplemental biologics license application 125249, ARCALYST (rilonacept) injection, Regeneron Pharmaceuticals, Inc., for the following proposed indication: "ARCALYST (rilonacept) is an interleukin-1 blocker indicated for the prevention of gout flares during initiation of uric-acid lowering therapy in adult patients with gout. ARCALYST has not been studied for longer than 16 weeks in this clinical setting.

Meeting Details:

Agenda: On May 7, 2012, the Pediatric Advisory Committee will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act, for Differin Lotion (adapalene), Dulera Inhalation Aerosol (mometasone furoate and formotorol fumarate), MultiHance Injection (gadobenate dimeglumine), Nasonex (mometasone furoate monohydrate), Natazia (estradiol valerate and estradiol valerate/dienogest), Omnaris Nasal Spray (ciclesonide), Protonix (pantoprazole), Tamiflu (oseltamivir phosphate), Taxotere (docetaxel) and Viread (tenofovir disoproxil fumarate). The committee will also receive an Informational Update on FDA’s KidNet pilot study. On May 8, 2012, the the Pediatric Advisory Committee will meet regarding the pediatricfocused safety reviews, as mandated by the Pediatric Research Equity Act, for Gardasil Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant, Isopto Carpine (pilocarpine hydrochloride), Menveo Meningococcal (Group A,C,Y, and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine, Zylet (loteprednol etabonate and tobramycin) and Zymaxid (gatifloxacin).

Meeting Details:

On April 25, 2012, the committee will discuss, make recommendations and vote on information related to a supplement to the premarket approval application (PMA) for the HeartWare Ventricular Assist System (HVAS) sponsored by HeartWare, Inc. The HVAS is an implantable electrically powered centrifugal-flow rotary blood pump with external driver and power source(s). It is the first ventricular assist device that does not require the creation of an abdominal pump pocket. The HVAS is indicated for use as a bridge to cardiac transplantation in patients who are at risk of death from refractory, advanced heart failure. On April 26, 2012, the committee will discuss, make recommendations and vote on information related to the PMA for the Subcutaneous Implantable Cardioverter Defibrillator (S–ICD) System sponsored by Cameron Health, Inc. The S–ICD is the first implantable defibrillator that does not require the implantation of an electrode either on or in the heart. The S–ICD is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias. The device is capable of delivering high energy defibrillation shocks as well as bradycardia demand mode cardiac pacing. The study provides data from the treatment of induced acute and chronic episodes of ventricular tachycardia/ventricular fibrillation and spontaneous episodes. In addition to the investigational device exemption study, clinical data were also obtained from using studies outside the United States and registries.