During the morning session of March 29, 2017, the Committee will discuss biologics license application (BLA) 761064, rituximab/hyaluronidase injection for subcutaneous use, submitted by Genentech, Inc. The proposed indications (uses) for this product are for: (1) 5 The treatment of patients with relapsed or refractory, follicular lymphoma as a single agent; (2) previously untreated follicular lymphoma in combination with first line chemotherapy and, in patients achieving a complete or partial response to rituximab/hyaluronidase for subcutaneous injection in combination with chemotherapy, as single-agent maintenance therapy; (3) nonprogressing (including stable disease), follicular lymphoma as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy; (4) the treatment of patients with previously untreated diffuse large B-cell lymphoma (DLBCL) in combination with cyclophosphamide, doxorubicin, vincristine, prednisolone (CHOP) or other anthracycline based chemotherapy regimens; and (5) in combination with fludarabine and cyclophosphamide (FC), for the treatment of patients with previously untreated and previously treated chronic lymphocytic leukemia (CLL).
The Committees will discuss safety issues associated with over-the-counter analgesic combination products used for upset stomach (i.e., heartburn, nausea, fullness, belching, gas, acid indigestion, and/or sour stomach) and hangover indications under the Internal Analgesic and Antacid monographs in 21 CFR part 343 and 21 CFR part 331, respectively. The Committees will also be asked to discuss the hangover indication under the Overindulgence, Internal Analgesic, and Stimulant monographs in 21 CFR part 357 subpart J, 21 CFR part 343, and 21 CFR part 340, respectively.
On April 4, 2017, in open session, the Committee will discuss Recombinant Human Coagulation Factor IX, GlycoPEGylated. In the afternoon, in open session, the Committee will hear an update presentation on a summary of responses to Docket FDA-2016-N- 1502: Blood Donor Deferral Policy for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products.
On April 5, 2017, in open session, the Committee will hear overview presentations on the research programs in the Laboratory of Emerging Pathogens in the Division of Emerging Transfusion-Transmitted Diseases, Office of Blood Research and Review, Center for Biologics Evaluation and Research, FDA. At the conclusion of the open session, the meeting will be closed to permit discussion where disclosure would constitute an unwarranted invasion of personal privacy in accordance with 5 U.S.C 552b(c)(6). During the closed session, the 3 Committee will discuss the research progress made by staff involved in the intramural research programs and make recommendations regarding their personnel actions and staffing decisions.
Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee
The Committees will discuss new drug application (NDA) 209777, for oxycodone hydrochloride immediate-release oral tablets, submitted by Inspirion Delivery Sciences, LLC with the proposed indication of management of moderate to severe pain where the use of an opioid analgesic is appropriate. The product has been formulated with properties intended to deter abuse, and the applicant has submitted data to support these abuse-deterrent properties for this product. The Committees will be asked to discuss the overall risk-benefit profile of the product, and whether the applicant has demonstrated abuse-deterrent properties for their product that would support labeling.
The Committee will review recommendations pertaining to the Common Rule and the use of real-world evidence for devices.
The use of model-informed drug development (MIDD) for new and generic drugs has significantly increased over the past several years. The Committee discussed strategies, approaches, and challenges in MIDD with specific focus on two areas. During the morning session, the Committee discussed approaches and evidentiary information needed for applying physiologically-based pharmacokinetic modeling and simulation throughout a drug’s lifecycle. During the afternoon session, the Committee discussed mechanistic model informed safety evaluation with a focus on drug potential for causing arrhythmias. The Comprehensive in Vitro Proarrhythmia Assay was discussed as an exemplar.
Drug Safety and Risk Management Advisory Committee (DSRM) and the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC)
The Committees discussed safety issues for new drug application (NDA) 201655, OPANA ER (oxymorphone hydrochloride) Extended-release Tablets, by Endo Pharmaceuticals Inc., with the indication of management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The product is an approved extended-release (ER) formulation intended to have abuse-deterrent properties based on its physicochemical properties, however, this information is not currently reflected in product labeling.
A majority of the Committee, 18 of 27 members, voted that the benefits of reformulated OPANA ER do not continue to outweigh its risks.
The Committee will meet to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2017-2018 influenza season.
The Committee will discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act, the Pediatric Research Equity Act and the Pediatric Medical Device Safety and Improvement Act .
On March 6, 2017, the Committee will discuss the following products (listed by FDA Center):
Center for Drug Evaluation and Research (CDER)
a. NITROPRESS (sodium nitroprusside)
b. KUVAN (sapropterin dihydrochloride)
FDA will provide the analysis of a possible safety signal regarding the use of the drug product EXJADE (deferasirox) in children with fever and dehydration, which was discussed at the September 2015 meeting.
The Committee will also discuss the role of pharmacogenomics in pediatric product development.
On March 7, 2017, the Committtee will discuss the following products (listed by FDA Center):
Center for Biologics Evaluation and Research (CBER)
a. EPICEL (cultured epidermal autografts) (humanitarian device exemption (HDE))
b. NOVOEIGHT (Antihemophilic Factor (Recombinant))
c. RIXUBIS Coagulation Factor IX (Recombinant)
Center for Devices and Radiological Health (CDRH)
a. IMPELLA RP SYSTEM (HDE)
b. LIPOSORBER LA-15 SYSTEM (HDE)
c. MEDTRONIC ACTIVA DYSTONIA THERAPY (HDE)
The Committee will discuss new drug application (NDA) 209241, Valbenazine 40 mg capsules, for the proposed treatment of Tardive Dyskinesia, submitted by Neurocrine Biosciences, Inc.
The ACHDNC heard presentations and held discussions on topics related to newborn screening (NBS) activities, technologies, policies, guidelines, and programs for effectively reducing morbidity and mortality in newborns and children having, or at risk for, heritable disorders.
The Committee also heard updates from the following workgroups:
· Education and Training Workgroup;
· Laboratory Standards and Procedures Workgroup; and
· Follow-up and Treatment Workgroup.
The ACHDNC did not vote on a proposed addition of a condition to the Recommended Uniform Screening Panel (RUSP)
The Committee dicussed appropriate clinical trial design features, including acceptable endpoints for demonstrating clinical benefit, for drugs intended to treat secondary hypogonadism while preserving or improving testicular function, including spermatogenesis
The Committee reviewed topics related to the safety of donated blood.
The Board heard reports from the FDA and discussed topics including: 1. Strategic goals for regulatory science at the Center for Biologics Evaluation and Research (CBER); 2. Progress updates on FDA’s Opioid Action Plan and the Bovine Heparin Initiative; 3. Response from the Office of Scientific Professional Development to the Science Board’s report on the Commissioner’s Fellowship Program; 4. Report from the Scientific Engagement Subcommittee; and 5. Report from the Food Emergency Response Network Cooperative Agreement Program Evaluation Subcommittee.
The Committee discussed and made recommendations on FDA’s draft Strategic Plan for Risk Communication and Health Literacy.
The Committee narrowly supported, by a vote of 7-Yes to 6-No, with no abstentions, the safety and efficacy of solithromycin capsules and solithromycin for injection, sponsored by Cempra Pharmaceuticals, Inc. (Cempra), for the proposed indication of the treatment of community-acquired bacterial pneumonia (CABP).
The Committee discussed five bulk drug substances nominated for inclusion on the section 503A Bulks List.
- Diindolylmethane - Treatment of cancer
- Glycolic acid - Hyperpigmentation (including melasma) and photodamaged skin
- Trichloroacetic acid - Common warts and genital warts
- Kojic acid - Hyperpigmentation and as a chelating agent to promote wound healing
- Vasoactive intestinal peptide - A condition described as “chronic inflammatory response syndrome”
The Committee also discussed drug products that employ transdermal and topical delivery systems, which were nominated for the Difficult to Compound List.
The Committee met to consider Guanidinoacetate Methyltransferase (GAMT) deficiency for a full evidence review for addition to the Recommended Uniform Screening Panel (RUSP). In addition, the Committee heard updates on topics related to newborn screening and medical foods.
The Committee will hear updates from the Centers for Disease Control and Prevention (CDC), the Centers for Medicare and Medicaid Services (CMS), and the Food and Drug Administration (FDA).
The Committee heard updates of research programs in the Laboratory of Immunobiochemistry of the Division of Bacterial, Parasitic and Allergenic Products (DBPAP), Office of Vaccines Research and Review (OVRR), Center for Biologics Evaluation and Research (CBER), FDA. The open session portion of the meeting occurred by teleconference from 1:00 PM – 2:20 U.S. EDT.
The Committee met to discuss topics related to human research protections.
The Committee supported, by a vote of 14-Yes to 4-No, with no abstentions, the safety and efficacy of desmopressin nasal spray, submitted by Serenity Pharmaceuticals, LLC (Serenity). However, the Committee members who supported approval felt that the sponsor’s proposed indication, the treatment of adult onset nocturia, was too broad, and they instead preferred a narrower indication (e.g., adult nocturnal polyuria).
The Committee agreed unanimously with the recommendations of the World Health Organization (WHO) in regard to the strains to include in influenza virus vaccines for the 2017 southern hemisphere influenza season.
Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee
A narrow majority of the Committee members, 15 of 28 members, voted that the FDA should change the current pharmacokineticstandard for approval of naloxone products for use in the community.
A majority of the Committee members, 21 of 28 members, voted that the FDA should not use different minimum standards to support the approval of products intended for use in adults and in children.
Anesthetic and Analgesic Drug Products Advisory Committee, the Drug Safety and Risk Management Advisory Committee, and the Pediatric Advisory Committee
The Committees discussed the appropriate development plans for establishing the safety and efficacy of prescription opioid analgesics for pediatric patients, including obtaining pharmacokinetic data and the use of extrapolation.
Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee
A majority of the Committee members, 10 of 19 members, voted that the FDA should remove the boxed warning statements regarding the risk of serious neuropsychiatric (NPS) adverse events (AEs) associated with Chantix.
Five of the 19 members voted that the FDA should keep the boxed warning statements.
Four of 19 members voted that the FDA should modify the language of boxed warning statements.
The Committee discussed pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act, the Pediatric Research Equity Act, and the Pediatric Medical Device Safety and Improvement Act.
The Committee did not support, by a vote of 0-Yes to 14-No, with no abstentions, the safety and efficacy of Qapzola (apaziquone) for intravesical instillation, by Spectrum Pharmaceuticals, Inc. (Spectrum). The proposed indication is immediate intravesical instillation post-transurethral resection of bladder tumors in patients with non-muscle invasive bladder cancer (NMIBC).
The Committee heard updates of research programs at FDA’s Center for Biologics Evaluation and Research (CBER).
The Committee discussed topics about tests for newborns, heard updates of its Workgroups and voted on a recommendation of its Pilot Study Workgroup.
Anesthetic and Analgesic Drug Products and the Drug Safety and Risk Management Advisory Committees (AADPAC-DSRM)
The Committees supported, by a vote of 18-Yes to 1-No, with no abstentions, the safety and efficacy of Arymo ER (morphine sulfate extended-release tablets), submitted by Egalet US, Inc. (Egalet), for the proposed indication of the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The Committees also voted that the data submitted by Egalet are sufficient to support labeling of the product as having properties expected to deter abuse.
The Committee heard updates of CDER research programs.
The Committee supported, by a vote of 14 for “Yes, but only if certain risk management options for Suicide Ideation and Behavior (SIB) beyond labeling are implemented”, the overall benefit/risk profile of brodalumab as acceptable to support approval for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. Four of the Committee members voted for “Yes, with labeling alone to manage the risks.” No members voted for “No.”
The Committee supported by a vote of 20-Yes to 0-No, with no abstentions, that the totality of the evidence supports licensure of GP2015, a proposed biosimilar to Amgen Inc.’s Enbrel (etanercept), submitted by Sandoz, Inc. (Sandoz), a unit of Novartis AG.