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
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
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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Apr
8
9:00 AM09:00

Pediatric Advisory Committee

On April 8, 2019, the PEDAC will meet to discuss drug development for testosterone replacement therapy in male adolescents for conditions associated with a deficiency or absence of endogenous testosterone resulting from structural or genetic etiologies (“classic hypogonadism”). The following topics will be considered for discussion: diagnosing male adolescents with classic hypogonadism, evidence to establish efficacy and safety of testosterone replacement therapy in this population, study design, and feasibility considerations for such studies. The committee will not discuss any individual research programs.

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Apr
10
to Apr 11

Clinical Laboratory Improvement Advisory Committee

The US Centers for Disease Control and Prevention (CDC) has announced that there will be a meeting of the Clinical Laboratory Improvement Advisory Committee (CLIAC) on Wednesday to Thursday, April 10-11, 2019 to hear updates from the CDC, the Centers for Medicare and Medicaid Services (CMS), and the Food and Drug Administration (FDA). Presentations and discussions will focus on an update from the CDC’s Office of Infectious Diseases (OID) Board of Scientific Counselors meeting and reports from three CLIAC workgroups: the Clinical Laboratory Improvement Amendments (CLIA) Personnel Regulations Workgroup, the Nontraditional Testing Workflow Model Workgroup, and the Next Generation Sequencing (NGS) Workgroup. Agenda items are subject to change as priorities dictate.

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Apr
15
to Apr 16

Advisory Committee on Blood and Tissue Safety and Availability Authority

The committee will meet to receive presentations from various public and private sector stakeholders and to listen to public comments regarding the Public Health Service Guidelines on Reducing HIV, HBV, and HCV through Organ Transplantation (“PHS Guidelines”). The Committee will explore important questions to consider as the PHS Guidelines are examined for any such necessary updates. Finally, the Committee will discuss and develop appropriate recommendations for HHS consideration. Additional topics that are pertinent to the mission of the Committee may be added to the agenda.

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Apr
26
8:30 AM08:30

Antimicrobial Drugs Advisory Committee

The committee will discuss 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 the only approved indication for bacitracin for intramuscular injection. The committee will also consider whether there are other uses for bacitracin for intramuscular injection that could be studied.FDA will present background information on the regulatory history of bacitracin for intramuscular injection and information on the current use of bacitracin for intramuscular injection.

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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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Oct
18
8:00 AM08:00

Gastrointestinal Drugs Advisory Committee

The committee met to discuss a new drug application (NDA) for Motegrity (prucalopride) tablets for oral administration, submitted by Shire Development, LLC (Shire), proposed for the treatment of chronic idiopathic constipation in adults.

The committee voted unanimously (10 of 10 members) that the clinical trial data provide substantial evidence of effectiveness of prucalopride for the treatment of adults with chronic idiopathic constipation (CIC).

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Oct
17
8:00 AM08:00

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

The committee met to discuss a supplemental new drug application (sNDA) for Zelnorm (tegaserod maleate) tablets for oral administration, submitted by Sloan Pharma S.à.r.l, Bertrange, Cham Branch (Sloan). Note that the Investigational New Drug (IND) application for Zelnorm was transferred from its initial holder, Novartis, to Sloan on November 24, 2015, and US World Meds, LLC is acting as an authorized agent for Sloan on the sNDA.

A majority of the Committee, 7 of 12 members, voted that “IBS-C females at low CV risk” is the patient population in whom they would expect the benefits to outweigh the risks. Three of 12 members voted that “IBS-C females at low CV risk and who are severely symptomatic” is the patient population in whom they would expect the benefits to outweigh the risks. One committee member voted that “IBS-C females,” with no qualification for CV risk, is the patient population in whom the benefits are expected to outweigh the risks. He elaborated that although the indication should be kept broad, labeling should include information about the both safety signals to guide prescribing. One Committee member voted for “other” because she felt the appropriate population is IBS-C females at low CV risk who are severely symptomatic and who are also at low psychiatric risk.

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Oct
12
8:00 AM08:00

Anesthetic and Analgesic Drug Products Advisory Committee

The committee met to discuss the resubmission of a new drug application (NDA) by AcelRx Pharmaceuticals, Inc. (AcelRx) for DSUVIA (sufentanil sublingual tablet 30 mcg), proposed for the management of moderate-to-severe acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate, in adult patients, in a medically supervised setting. The committee was asked to discuss risk-benefit considerations and whether this product should be approved.

A majority of the committee, 10 of 13 members, voted that the benefits of DSUVIA, with the Risk Evaluation and Mitigation Strategies (REMS) proposed by the FDA, outweigh the risks for the proposed moderate-to-severe pain indication, supporting its approval.

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Oct
11
8:00 AM08:00

Anesthetic and Analgesic Drug Products Advisory Committee

The committee met to discuss a new drug application (NDA) for oliceridine (0.1 mg/milliliter and 0.35 mg/milliliter), submitted by Trevena, Inc. (Trevena), proposed for the management of moderate-to-severe acute pain in adult patients for whom an intravenous (IV) opioid is warranted. The committee was asked to discuss the efficacy and safety data and benefit-risk considerations.

A narrow majority of the committee, 8 of 15 members, recommended that the FDA should not approve oliceridine for the proposed management of moderate-to-severe acute pain in adults for whom an IV opioid is warranted.

 

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Oct
10
8:00 AM08:00

Oncologic Drugs Advisory Committee

The committee discussed the resubmission of a biologics license application (BLA) for CT-P10, a proposed biosimilar of Rituxan (rituximab) by Celltrion, Inc. (Celltrion). Pending licensure, Teva Pharmaceutical Industries, Ltd is responsible for all commercial activities of CT-P10 in the US.

The committee voted unanimously (16 of 16 member) that the totality of the evidence support the licensure of CT-P10 as a biosimilar product of Rituxan for the following three indications:

·      relapsed or refractory, low-grade or follicular, CD20-positive, B-cell Non–Hodgkin’s Lymphoma (NHL) as a single agent;

·      previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy; and

·      non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.

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Sep
20
8:00 AM08:00

Pharmaceutical Science and Clinical Pharmacology Advisory Committee

The committee discussed and voted on two topics related to the Office of Pharmaceutical Quality's priority of promoting the availability of better medicine. The first topic was the modernization of generic drug applications through a Knowledge-aided Assessment & Structured Application (KASA) initiative. The committee members were unanimous, by a vote of 10-Yes to 0-No, with no abstentions, in their support of the development of a structured application as a part of the KASA initiative. The second topic involved the establishment of patient focused quality standards for extended-release solid oral drug products. The committee members were unanimous, by a vote of 11-Yes to 0-No, with no abstentions, in their recommendation that the FDA establish patient-focused dissolution standards for extended-release solid oral dosage forms. Note that one of the members of the committee attended and voted only in the Topic II session.

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Sep
20
8:00 AM08:00

Pediatric Advisory Committee

The committee heard pediatric-focused safety reviews for Intuniv (guanfacine) and Lexapro (escitalopram). For each of these drugs, the committee voted in favor, by a vote of 11-Yes and 1No, of the monitoring proposed by the FDA’s Division of Pharmacovigilance (DPV). For Intuniv, the DPV proposed to continue monitoring for adverse events (AEs), including suicidal ideation and behavior, pancreatitis, and medication error involving name confusion. For Lexapro, the DPV proposed to continue routine safety monitoring

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Sep
12
8:00 AM08:00

Pharmacy Compounding Advisory Committee

The Committee agreed unanimously with the FDA’s recommendation to include the following four bulk drug substances on the list of bulk substances allowed for compounding: alpha lipoic acid (solid oral dosage); coenzyme Q10 (for oral administration); creatine monohydrate (solid oral dosage forms); and pyridoxal 5 phosphate (intravenous and oral dosage forms).

The Committee agreed unanimously with the FDA’s recommendation to exclude quercetin dihydrate on the list of bulk substances allowed for compounding.

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Aug
8
8:30 AM08:30

Antimicrobial Drugs Advisory Committee

The Committee discussed new drug applications (NDAs) for omadacycline tablets and injection, sponsored by Paratek Pharmaceuticals, Inc. (Paratek), for the proposed indications for the treatment of community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections.

A majority of the Committee, 17 of 18 members, voted that Paratek has provided substantial evidence of the safety and effectiveness of omadacycline for the treatment of acute bacterial skin and skin structure infections (ABSSSI).

A majority of the Committee, 14 of 18 members, voted that Paratek has also provided evidence of the safety and effectiveness of omadacycline for the treatment of community acquired bacterial pneumonia (CABP).

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Aug
7
8:30 AM08:30

Antimicrobial Drugs Advisory Committee

The Committee discussed a new drug application (NDA) for amikacin liposome inhalation suspension (ALIS), sponsored by Insmed, Inc. (Insmed), for the proposed indication of treatment of nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC) in adults, as part of a combination antibacterial drug regimen.

A majority of the Committee, 12 of 14 members, voted that Insmed has provided substantial evidence of the effectiveness and sufficient evidence of the safety of ALIS for the treatment of nontuberculous mycobacterial lung disease caused by MAC, as part of a combination antibacterial drug regimen, for adult patients with limited or no treatment options. A same majority of the Committee, 12 of 14 members, did not support broader use for all adult patients with the disease.

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