Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming FDA advisory committee meetings and a summary of topics covered.

Topic	Advisory Committee	Date
Otsuka Pharmaceutical Company Ltd.’s tolvaptan tablets for slowing kidney disease in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease	Cardiovascular and Renal Drugs	Aug. 5
Bayer HealthCare Pharmaceuticals Inc.’s Adempas (riociguat) for treatment of (1) chronic thromboembolic pulmonary hypertension World Health Organization Group 4 to improve exercise capacity and WHO functional class and (2) pulmonary arterial hypertension (WHO Group 1) to improve exercise capacity, improve WHO functional class and delay clinical worsening	Cardiovascular and Renal Drugs	Aug. 6
Discussion of how FDA can communicate more effectively with health care professionals and other stakeholders about the public health risks posed by counterfeit and unapproved drugs, in addition to safe purchasing practices, and how FDA can evaluate that communication and its impact	Risk Communications	Aug. 16
Discussion of ethical issues in pediatric product development, including medical countermeasures, focusing on the concepts of minimal risk, disorder or condition, and exposure of pediatric subjects to risks under 21 CFR 50.54	Pediatric Advisory Committee/Ethics Subcommittee	Sept. 9-10
GlaxoSmithKline’s Anoro Ellipta (umeclidinium/vilanterol powder) for long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema	Pulmonary-Allergy Drugs	Sept. 10
Genentech’s Perjeta (pertuzumab) in combination with trastuzumab and docetaxel for the neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory or early-stage breast cancer as part of a complete regimen containing either fluorouracil, epirubicin and cyclophosphamide or carboplatin	Oncologic Drugs	Sept. 12
Discussion of optimal strategies for the evaluation, interpretation and communication of drug-drug interaction (DDI) information	Pharmaceutical Science and Clinical Pharmacology	Sept. 25
Amarin’s Vascepa (icosapent ethyl) for concomitant use with a statin to reduce triglycerides, non-high density lipoprotein cholesterol, apolipoprotein B, low density lipoprotein cholesterol, total cholesterol and very low density lipoprotein cholesterol in adults with mixed dyslipidemia and coronary heart disease or a CHD risk equivalent	Endocrinologic and Metabolic Drugs	Oct. 16
Discussion of the role of pharmacokinetic data in setting susceptibility interpretive criteria for systemic antibacterial drugs and revising dosing recommendations in labeling based on PK, clinical safety and efficacy data	Anti-Infective Drugs	Oct. 17
Paladin Therapeutics Inc.’s miltefosine for the treatment of patients with visceral, mucosal and cutaneous leishmaniasis	Anti-Infective Drugs	Oct. 18
Updates on guidance documents issued by the Center for Biologics Evaluation and Research’s Office of Cellular, Tissue and Gene Therapies; considerations for the design of early-phase clinical trials of cellular and gene therapy products	Cellular, Tissue and Gene Therapies	Oct. 23