The Committee will discuss and make recommendations on the safety and effectiveness of Zoster Vaccine Recombinant, Adjuvanted, manufactured by GlaxoSmithKline Biologicals.
Anesthetic and Analgesic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee
The Committees will discuss sNDAs for BUTRANS (buprenorphine) transdermal system submitted by Purdue Pharma L.P., evaluating BUTRANS in pediatric patients ages 7 through 16 years for 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 will be asked to discuss the findings of the clinical study of BUTRANS conducted in pediatric patients, and whether they support additional labeling.
The Committee will discuss a supplemental new drug application for SUTENT (sunitinib malate) oral capsules, submitted by C.P. Pharmaceuticals International C.V., represented by Pfizer, Inc. (authorized U.S. agent). The proposed indication for this product is for the adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma following nephrectomy.
The Committee met to hear presentations and conduct discussions on topics related to newborn screening 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 supported by a vote of 10-Yes to 1-No, with no abstentions, the approval of XELJANZ (tofacitinib) tablets and XELJANZ XR (tofacitinib) extended-release (XR) tablets, submitted by Pfizer Inc. (Pfizer), for the treatment of adult patients with active psoriatic arthritis.
The Committee voted against recommending approval, by a vote of 1-Yes to 12-No, with no abstentions, of sirukumab injection (proposed trade name PLIVENSIA), by Janssen Biotech, Inc. (Janssen), for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs).
The Committee supported, by a vote of 12-Yes to 1-No, with 3 abstentions, the safety of Heplisav-B [Hepatitis B Vaccine, Recombinant (Adjuvanted)] by Dynavax Technologies Corporation when administered to adults aged 18 years and older. The FDA’s goal date to decide on whether to approve Heplisav-B is August 10, 2017.
Anesthetic and Analgesic Drugs Advisory Committee and Drug Safety and Risk Managment Advisory Committee
The Committees voted that Rexista (oxycodone extended-release tablets), submitted by Intellipharmaceutics Corp. (Intellipharmaceutics) should not be approved, by a vote of 1-Yes and 22-No,. The proposed indication of Rexista is the management of moderate-to-severe pain when a continuous around-the-clock analgesic is needed for an extended period of time. The Committees also voted in regard to the company’s proposed label claim regarding abuse-deterrence. The FDA’s decision goal date for the Rexista New Drug Application (NDA) is September 25, 2017.
On Tuesday and Wednesday, July 25-26, 2017, the Secretary’s Advisory Committee on Human Research Protections (SACHRP) met to discuss topics related to human research protections. The Committee reviewed recommendations pertaining to the new Common Rule, the Federal Policy for the Protection of Human Subjects under 45 CFR, Part 46.
In the morning session, the Committee supported, by a vote of 17-Yes to 0-No, with no abstentions, the licensure of ABP-215 as a biosimilar to Genentech/Roche’s Avastin (bevacizumab), submitted by Amgen Inc. (Amgen). Amgen has developed ABP-215 in collaboration with Allergan.
In the afternoon session, the Committee supported, by a vote of 16-Yes to 0-No, with no abstentions, the licensure of MYL-1401O as a biosimilar to Genentech Inc.’s Herceptin (trastuzumab), submitted by Mylan GmbH (Mylan). Mylan is developing MYL-1401O in collaboration with Biocon Ltd.
The Committee supported, by a vote of 10-Yes to 0-No, with no abstentions, the safety and efficacy of tisagenlecleucel by Novartis Pharmaceuticals Corp. (Novartis) for the treatment of pediatric and young adult patients 3 to 25 years of age with relapsed/refractory (r/r) B-cell precursor acute lymphoblastic leukemia (ALL).
The PDUFA date, which is the FDA’s goal date to make an approval decision, is October 3, 2017.
The Committee supported, by a vote of 6-Yes to 1-No, with no abstentions, the safety and efficacy of Mylotarg (gemtuzumab ozogamicin) by Wyeth Pharmaceuticals Inc. (Wyeth), a subsidiary of Pfizer Inc., for the treatment of certain patients with acute myeloid leukemia (AML).
The Committee (ODAC) discussed potential pediatric development plans/written requests for: (1) APX005M, presentation by Apexigen, Inc. (Apexigen); (2) PMO1183 (lurbinectedin), presentation by PharmaMar USA Inc. (PharmaMar); (3) ASP2215 (gilteritinib), presentation by Astellas Pharma Global Development, Inc. (Astellas); (4) Prexasertib, presentation by Dista Products/Eli Lilly and Company (Lilly); and (5) Olaratumab, presentation by Eli Lilly and Company.
The Committee supported, by a vote of 17-Yes to 2-No, with no abstentions, proposed cardiovascular claims for Victoza (liraglutide) injection, by Novo Nordisk.
The Committee met to discuss topics related to human research protections. The Committee reviewed recommendations pertaining to the new “Common Rule” (the Federal Policy for the Protection of Human Subjects) and recent FDA Draft Guidance regarding the use of real-world evidence to support regulatory decision-making for medical devices.
The Committee supported by a vote of 12-Yes to 4-No, with no abstentions, the risk-benefit profile of neratinib maleate by Puma Biotechnology (Puma) for the extended adjuvant treatment of human epidermal growth factor receptor 2 (HER2)-overexpressed/amplified in adult breast cancer patients who have received prior therapy with trastuzumab (US trade name Herceptin).
In the afternoon session, the Committee supported, by a vote of 10-Yes to 3-No, with no abstentions, the risk-benefit profile of L-glutamine by Emmaus Medical, Inc. (Emmaus) for the treatment of Sickle Cell Disease.
The Committees jointly supported, by a vote of 14-Yes to 0-No, with no abstentions, the use of an indwelling central venous access devices, in certain circumstances, in the clinical trial “A Double-Blind, Placebo-Controlled, Multicenter Study With an Open-Label Extension to Evaluate the Efficacy and Safety of SRP-4045 and SRP-4053 in Patients with Duchenne Muscular Dystrophy (ESSENCE).”
The Committee discussed considerations for evaluation of Respiratory Syncytial Virus vaccine candidates in seronegative infants.
The Committee met to consider Spinal Muscular Atrophy (SMA) 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 (NBS) and medical foods.
The Board met to provide recommendations on the Agency’s work plan on the allocation of innovation funds. Section 1002 of the 21st Century Cures Act provides $495 million in funding to the FDA from fiscal year (FY) 2017 through FY 2025 for FDA Innovation Projects. The Act requires the FDA Commissioner to submit a work plan that describes the budget for planned activities and provides justification based on advancing public health. The plan must be submitted by June 11, 2017, which is within 180 days of the bill’s passage (December 13, 2016). The Act states that prior to submitting the work plan to Congress, the Commissioner must seek recommendations from the SBFDA and include these recommendations in the work plan.
The Committee discussed and voted on substances that were nominated for the list of bulk drug substances allowed for compounding and on products that were nominated for the difficult to compound list (as per sections 503A and 503B of the Food, Drug & Cosmetic Act).
· A majority of the Committee members agreed with the FDA’s recommendation to exclude the following 6 bulk drug substances on the substances allowed list: nicotinamide adenine dinucleotide, nicotinamide adenine dinucleotide disodium reduced, nettle, ubiquinol, vanadyl sulfate, and artemisinin.
· A majority of the Committee members agreed with the FDA’s recommendation to include oral solid modified release drug products that employ coated systems on the products that are difficult to compound list.
· The Committee also heard an update from the FDA in regard to inspections.
The Committee discussed the development of antibacterial drugs that treat a single species of bacteria when the target species infrequently causes infections. Overall, the Committee supported the conduct of non-inferiority trials with expanded margins to support approval. The Committee did not support the use of data obtained from studies of animal models as a sole basis for approval.
Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee
The Committees jointly supported, by a vote of 19-Yes to 0-No, with one abstention, the approval of RoxyBond, oxycodone immediate-release (IR) tablets, submitted by Inspirion Delivery Sciences, LLC (IDS) with the proposed indication of management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
A majority of the Committees, 19 of 20 members, voted that, if approved, RoxyBond should be labeled as an abuse-deterrent product by the IN route of abuse.
A majority of the Committees, 16 of 20 members, voted that, if approved, RoxyBond should be labeled as an abuse-deterrent product by the IV route of abuse.
The Committee met to discuss Novo Nordisk’s Biologics License Application (BLA 125611), for Recombinant Human Coagulation Factor IX, GlycoPEGylated. The product is also referred to as nonacog beta pegol or N9-GP.
In a separate Tuesday afternoon session, the Committee heard 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 Wednesday, April 5, 2017, the Committee heard 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.
The Committees did not support, by a vote of 5-Yes to 15-No, with no abstentions, that the combination of an analgesic with an antacid is a rational combination for the over-the-counter (OTC) use to relieve minor aches and pains associated with heartburn, sour stomach, acid indigestion, fullness, belching, gas, or nausea. The Committees also expressed concerns with the hangover indication of several OTC monographs.
The Committee unanimously supported, by a vote of 11-Yes to 0-No, with no abstentions, the safety and efficacy of rituximab/hyaluronidase injection for subcutaneous use, by Genentech, Inc. (Genentech), to treat patients with certain types of lymphoma and leukemia.
The goal date for the FDA to decide on approval (the PDUFA date) is June 26, 2017.
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.