Jun
20
8:00 AM08:00

Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee

During the morning session, the committee will review and discuss the FDA Reauthorization Act of 2017 (FDARA) mandated Relevant Pediatric Molecular Target List now posted on the FDA website The focus of the discussion will be limited to two target “classes” included in the Relevant Pediatric Molecular Target List: (1) targets linked to cell lineage and (2) targets on normal immune cells and cells in the tumor microenvironment.  Planned introductory presentations will be on: (1) cell-based therapy approaches to childhood cancer and (2) novel membrane antigen determinants in pediatric tumors.

During the afternoon session, information will be presented to gauge investigator interest in exploring potential pediatric development plans for two products in various stages of development for adult cancer indications. The subcommittee will consider and discuss issues concerning diseases to be studied, patient populations to be included, and possible study designs in the development of these products for pediatric use.  The discussion will also provide information to the Agency pertinent to the formulation of written requests for pediatric studies, if appropriate.  The products under consideration are: (1) ONC201, presentation by Oncoceutics  Inc., and (2) CD24Fc, presentation by OncoImmune, Inc.

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Jul
25
8:30 AM08:30

Arthritis Advisory Committee

The committee will discuss supplemental new drug application (sNDA) 205832 for nintedanib capsules (drug name OFEV), sponsored by Boehringer Ingelheim, for the treatment of systemic sclerosis-associated interstitial lung disease (SSc-ILD). The focus of the discussion will be whether the application provides substantial evidence of efficacy for the proposed indication.

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Jun
11
to Jun 12

Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee

The FDA is seeking public input on the clinical utility and safety concerns associated with the higher range of opioid analgesic dosing (both in terms of higher strength products and higher daily doses) in the outpatient setting. The FDA is interested in better understanding current clinical use and situations that may warrant use of higher doses of opioid analgesics. The FDA is also interested in discussing the magnitude and frequency of harms associated with higher doses of opioid analgesics relative to lower doses, as well as optimal strategies for managing these risks while ensuring access to appropriate pain management for patients.

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Jun
6
8:00 AM08:00

Antimicrobial Drugs Advisory Committee

On Thursday, June 6, 2019, the Antimicrobial Drugs Advisory Committee (AMDAC) met to discuss a new drug application (NDA) for pretomanid tablets, submitted by The Global Alliance for TB Drug Development, Inc. (TB Alliance). The proposed use is in combination with bedaquiline and linezolid in adults for the treatment of pulmonary extensively drug resistant tuberculosis (XDR-TB) or treatment-intolerant or nonresponsive multidrug-resistant tuberculosis (TI/NR MDR-TB).

A majority of the committee, 14 of 18 members voted that pretomanid NDA provided substantial evidence of the effectiveness, and sufficient evidence of the safety, for the proposed use to treat adults with XDR-TB or TI/NR MDR-TB.

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May
14
8:00 AM08:00

Oncologic Drugs Advisory Committee

On Tuesday, May 14, 2019, the Oncologic Drugs Advisory Committee (ODAC) met to discuss two new drug applications (NDAs) submitted by Daiichi Sankyo, Inc. (Daiichi Sankyo).

During the morning session, the committee discussed an NDA for Turalio (pexidartinib) capsules, for the proposed indication to treat adults with symptomatic tenosynovial giant cell tumor (TGCT), also referred to as giant cell tumor of the tendon sheath (GCT-TS) or pigmented villonodular synovitis (PVNS), which is associated with severe morbidity or functional limitations, and which is not amenable to improvement with surgery. A majority of the committee, twelve of 15 members voted that the demonstrated benefit of pexidartinib outweighs the risks for the proposed use.

During the afternoon session, the committee discussed an NDA for quizartinib tablets, for the proposed treatment of adults with relapsed or refractory acute myeloid leukemia (AML), which is FLT3-ITD positive, as detected by an FDA-approved test. A majority of the committee, eight of 11 members, voted that the results of Study AC220-007 do not demonstrate that treatment with quizartinib provides for a benefit that outweighs the risk in the proposed population. (FLT3 = FMS-like tyrosine kinase 3; ITD = internal tandem duplication)

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May
8
8:00 AM08:00

Pulmonary-Allergy Drugs Advisory Committee

The committee discussed a new drug application for mannitol inhalation powder, for oral inhalation submitted by Chiesi USA, Inc., for the proposed indication of management of cystic fibrosis to improve pulmonary function in patients 18 years of age and older in conjunction with standard therapy.

A narrow majority of the committee, nine of 16 members, voted that the benefit-risk profile is adequate to support approval for the proposed use. Seven of 16 members voted that the benefit-risk profile is not adequate to support approval for the proposed use.

The committee also voted separately on the adequacy of the efficacy and the safety data.

A majority of the committee, ten of 16 members, voted that the data provide substantial evidence of efficacy for inhaled mannitol for the proposed use. Six members voted that the data do not provide substantial evidence of efficacy for the proposed use.

The same majority of the committee member, ten of 16 members, voted that the safety data are adequate to support approval for the proposed use. Six members voted that the safety data are not adequate for the proposed use.

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Apr
26
8:30 AM08:30

Antimicrobial Drugs Advisory Committee

The committee discussed the safety and effectiveness of bacitracin for intramuscular injection for the treatment of infants with pneumonia and empyema caused by staphylococci shown to be susceptible to the drug, which is its only approved indication.

A majority of the committee, 17 of 18 members, voted that the benefits of bacitracin for intramuscular injection do not outweigh the risks for its approved indication of the treatment of infants with pneumonia and empyema caused by staphylococci shown to be susceptible to the drug. One committee member abstained from voting.

The committee also gave input on potential uses for bacitracin for intramuscular injection that could be studied.

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Mar
27
8:00 AM08:00

Cancelled: Pulmonary-Allergy Drugs Advisory Committee

The committee will discuss new drug application (NDA) 208646, submitted by AllerQuest, LLC, for a skin-test kit (proposed trade name PRE-PEN Plus) that combines the approved product PRE-PEN (benzylpenicilloyl polylysine for injection) with penicillin G potassium, penicilloic acid, penilloic acid, and amoxicillin sodium, for the proposed indication to detect IgE sensitization to penicillin antigens and reliably rule out the potential for immediate life-threatening penicillin allergic reactions with a high degree of probability in patients with history of possible IgE-dependent penicillin allergy. The discussion will include study design considerations, the contribution of each of the components, and whether the submitted data provide substantial evidence of efficacy.

Update: On March 11, 2019, the FDA cancelled this meeting  “due to new information regarding the application.” The FDA added that they intend to continue evaluating the application and, as needed, will announce future meeting dates in the Federal Register.

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Mar
22
8:30 AM08:30

Vaccines and Related Biological Products Advisory Committee

OOn March 22, 2019, in follow-up to a delay by the World Health Organization (WHO) in recommending H3N2 strain for inclusion in the 2019-2020 seasonal influenza vaccines, the Center for Biologics Evaluation and Research reconvened the VRBPAC to discuss and make recommendations specifically on the H3N2 strain. The VRBPAC previously met on March 6, 2019, and made recommendations on the selection of all other strains to be included in seasonal influenza virus vaccines for the 2019-2020 influenza season. The committee unainimously agreed (10 of 10 members) with the WHO’s recommendation.

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Mar
21
to Mar 22

Blood Products Advisory Committee

In the afternoon, the committee met in open session to hear an overview of the research programs in the Laboratory of Biochemistry and Vascular Biology in the Division of Blood Components and Devices, Office of Blood Research and Review, Center for Biologics Evaluation and Research, FDA.

On March 21, 2019, the committee met in open session to discuss blood donation policies regarding men who have sex with men (MSM). The committee heard presentations on the current epidemiology of HIV in the United States; global developments in MSM blood donor deferral policies; and data on HIV incidence and prevalence among blood donors from the Transfusion-Transmitted Infection Monitoring System. The committee discussed a proposed HIV risk questionnaire study. In addition, the committee discussed a proposal for the use of pathogen reduction technology as an alternative procedure to a time-based deferral for MSM.  

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Mar
6
to Mar 7

Vaccines and Related Biological Products Advisory Committee

CBER Research

The committee heard an overview of the research programs in the Laboratory of Immunoregulation (LIR) and the Laboratory of Retroviruses (LR), Division of Viral Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research (CBER), FDA.

Flu strain vote

The committee voted unanimously (14 of 14 members) in agreement with the WHO’s recommendations for the northern hemisphere 2019-2020 season.

Dengvaxia vote

A majority of the committee, 13 of 14 members, voted that the available data are adequate to support the effectiveness of Dengvaxia for the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3, and 4 in individuals 9 through less than 17 years of age with laboratory-confirmed previous dengue infection and living in endemic areas.

A majority of the committee, 10 of 14 members, voted that the available data are adequate to support the safety of Dengvaxia for this use.

A majority of the committee, 7 of 14 members, including one member who abstained from voting), voted that the available data are not adequate to support the effectiveness of Dengvaxia for Sanofi’s proposed use, which was the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3, and 4 in individuals 9 through 45 years of age with laboratory-confirmed previous dengue infection and living in endemic areas.

The committee was split regarding whether the safety was adequately demonstrated for this use.

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Feb
26
12:30 PM12:30

Oncologic Drugs Advisory Committee

The committee held a half-day (afternoon) meeting to discuss a new drug application (NDA) for selinexor tablets, application submitted by Karyopharm Therapeutics, Inc. (Karyopharm), for use, in combination with dexamethasone, in the treatment of patients with relapsed refractory multiple myeloma who have received at least three prior therapies and whose disease is refractory to at least one proteasome inhibitor (PI), at least one immunomodulatory agent (IMiD), and an anti-CD38 monoclonal antibody.

A majority of the committee, eight of 13 members, voted to recommend delaying selinexor’s approval until results of an ongoing, randomized phase 3 trial, named BOSTON, become available.

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Feb
12
8:00 AM08:00

Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee

The committees met to discuss the efficacy, safety, and risk-benefit profile of a new drug application (NDA) for esketamine nasal spray, submitted by Janssen Pharmaceuticals, Inc. (Janssen), for the treatment of treatment-resistant depression (TRD). The votes of the joint committee supported approval.

A majority of the joint committee, 14 of 17 members, voted that Janssen has provided substantial evidence of the effectiveness of esketamine for the treatment of treatment-resistant depression (TRD). Two committee members voted that the company has not provided substantial evidence of effectiveness for the proposed use. One member abstained from voting.

A majority of the joint committee, 15 of 17 members, voted that Janssen has adequately characterized the safety profile of esketamine for the treatment of TRD. Two committee members voted that the safety profile was not adequately characterized.

A majority of the joint committee, 14 of 17 members, voted that, given the effectiveness and safety of esketamine and the FDA’s proposed risk evaluation and mitigation strategy (REMS), the benefits outweigh the risks of esketamine for the treatment of TRD.

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Jan
17
8:00 AM08:00

Endocrinologic and Metabolic Drugs Advisory Committee

The committee discussed a new drug application (NDA) for Zynquista (sotagliflozin) oral tablet, sponsored by Sanofi-Aventis US, LLC (Sanofi), for the proposed indication of use as adjunct to insulin therapy to improve glycemic control in adults with type 1 diabetes mellitus. Zynquista is being developed in partnership with Lexicon Pharmaceuticals, Inc. The committee was split on whether to recommend approval, resulting in eight members who voted for approval, and eight members who voted against approval.

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Jan
16
8:00 AM08:00

Bone, Reproductive and Urologic Drugs Advisory Committee

The committee discussed a biologics license application (BLA) for Evenity (romosozumab) injection, submitted by Amgen, for the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant of other available osteoporosis therapy.. A majority of the committee, 16of 19 members, voted that the overall benefit/risk profile of romosozumab is acceptable to support approval for the proposed osteoporosis use.

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Jan
11
8:00 AM08:00

Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee

The committees met jointly to discuss the results of a postmarketing cardiovascular safety study for Uloric (febuxostat) that were submitted in a supplemental new drug application (sNDA) by Takeda Pharmaceuticals (Takeda). The joint committee gave input on the cardiovascular safety and overall benefit:risk profile of febuxostat, and recommended possible regulatory actions by the FDA. A majority of the joint committee, 19 of 22 members, voted that, based upon the available data, there is a patient population in which the benefit-risk profile for febuxostat is favorable for the treatment of hyperuricemia in patients with gout.

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Dec
17
to Dec 18

Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee

The joint Committee discussed strategies to increase the availability of naloxone-containing products intended for use in the community. A narrow majority of the joint Committee, 12 of 23 members, voted that labeling language that recommends co-prescription of naloxone for all or high-risk patients prescribed opioids would be an effective method for expanding access to naloxone and improving public health.

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Nov
14
8:00 AM08:00

Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee

The committees met jointly to discuss a 505(b)(2) new drug application (NDA) for an immediate-release (IR) oral tablet formulation of oxycodone, named MNK-812, which is formulated with the intent to resist common methods of physical or chemical manipulation and to deter intravenous and intranasal abuse. A majority of the joint committee, ten of 17 members, voted that MNK-812 should be approved for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. A majority of the joint committee, twelve of 17 members, voted that, if approved, MNK-812 should be labeled as an abuse-deterrent product (ADP) by the nasal route of abuse. A majority of the joint committee, ten of 17 members, voted that if MNK-812 is approved, it should not be labeled as an ADP by the intravenous route of abuse.

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Nov
2
8:00 AM08:00

Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee

The committees met jointly to discuss the efficacy, safety, and benefit-risk profile of a new drug application for Zulresso (brexanolone) 5 mg/mL intravenous injection, submitted by Sage Therapeutics (Sage), for the proposed indication of postpartum depression (PPD). The joint committee voted nearly unanimously (17 of 18 membersr) in favor of recommending approval.

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Nov
1
to Nov 2

Advisory Committee on Heritable Disorders in Newborns and Children

The committee heard from experts in the field and discuss issues related to newborn screening information, education, training activities, and training resources. The committee also heard presentations on the use of genomic sequencing in newborn screening as well as the clinical setting for both well and sick infants. In addition, the committee discussed the nomination of cerebrotendinous xanthomatosis (CTX) to the RUSP.

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Nov
1
8:00 AM08:00

Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee

The joint committee met to discuss the efficacy, safety, and risk-benefit profile of the new drug application (NDA) for ALKS-5461 (buprenorphine and samidorphan sublingual tablets), submitted by Alkermes, Inc. (Alkermes), for adjunctive treatment of major depressive disorder (MDD).

A majority of the joint committee, 21 of 23 members, voted that the available data do not support a favorable benefit-risk profile of ALKS-5461 to support its approval. Two of 23 joint committee members voted that the available data do support its approval.

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Oct
24
to Oct 25

Endocrinologic and Metabolic Drugs Advisory Committee

The committee discussed the cardiovascular risk assessment of drugs for the treatment of type 2 diabetes mellitus and related FDA guidance (“Guidance for Industry: Diabetes Mellitus – Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes” (2008)).

A narrow majority of the committee, 10 of 19 members, voted that an unacceptable increase in cardiovascular risk should be excluded for all new drugs to improve glycemic control in patients with type 2 diabetes, regardless of the presence or absence of a signal for cardiovascular risk in the development program.

A narrow minority of the committee, 9 of 19 members, voted that an unacceptable increase in cardiovascular risk should not be excluded for all new drugs to improve glycemic control in patients with type 2 diabetes, regardless of the presence or absence of a signal for cardiovascular risk in the development program.

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Oct
22
9:00 AM09:00

Science Board to FDA

The SBFDA heard a response from the Center for Veterinary Medicine (CVM) to the recommendations made by the Science Board’s 2017 review of CVM’s National Antibiotic Resistance Monitoring System (NARMS) program. The Science Board also discussed potential hazards and nutritional considerations in the production of food derived from animal cell culture technologies. 

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