FDA Advisory Committees - FDA Center for Drug Evaluation and Research (CDER) - Arthritis Advisory Committee (AAC)
The committees will discuss supplemental new drug application (sNDA) 021-856, ULORIC (febuxostat) tablets, sponsored by Takeda Pharmaceuticals, which includes the results from the postmarketing safety trial required by FDA to evaluate the cardiovascular safety of febuxostat, entitled “Cardiovascular Safety of Febuxostat and Allopurinol in Patients with Gout and Cardiovascular Morbidities (CARES).” Febuxostat is a xanthine oxidase inhibitor indicated for the chronic management of hyperuricemia in patients with gout. The committees' discussion will include the results from the CARES trial, the benefit risk assessment of febuxostat, and potential regulatory actions.
The Committees met jointly to review and provide input on safety data from the PRECISION trial, a cardiovascular outcomes trial that compared Celebrex (celecoxib) to ibuprofen and naproxen, that was submitted by Pfizer, Inc. (Pfizer) in a supplemental new drug application (sNDA). The FDA also sought input on whether the findings of the trial should change the Agency’s current understanding of the safety of three nonsteroidal anti-inflammatory drugs (NSAIDs), including interpreting drug interactions between the three drugs and aspirin in patients taking aspirin for secondary prevention of cardiovascular disease.
The Committee voted in favor of approval of the proposed 2 mg dose of baricitinib tablets and against approval of the proposed 4 mg dose of baricitinib tablets, submitted by Eli Lilly and Company, for the treatment of adult patients with moderately to severely active rheumatoid arrthritis who have had an inadequate response or intolerance to methotrexate.
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 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.
The Committee supported, by a vote of 26-Yes to 0-No, with no abstentions, that the totality of the evidence supports licensure of ABP 501, submitted by Amgen, Inc. (Amgen), as a proposed biosimilar to AbbVie Inc.'s Humira (adalimumab).
The Committee voted in support, by a vote of 21-Yes to 3-No, with no abstentions, of the licensure of Celltrion Inc’s CT-P13 as a biosimilar product to Remicade (infliximab) for each of the indications for which Remicade is currently licensed: Rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA), plaque psoriasis (PsO), ulcerative colitis (UC), and adult and pediatric Crohn’s disease (CD).
The FDA is expected to issue its decision by April 6, 2016. If approved, Pfizer will commercialize CT-P13 in the U.S. under the proposed trade name Inflectra.
On Friday, October 23, 2015, the Arthritis Advisory Committee (AAC) supported, by a vote of 10-Yes to 4-No, with no abstentions, the safety and efficacy of lesinurad oral tablets, submitted by Ardea Biosciences, Inc. (Ardea), for the treatment of hyperuricemia associated with gout, in combination with a xanthine oxidase inhibitor (XOI). As of June 2012, Ardea has been a wholly-owned subsidiary of AstraZeneca, Inc. (AstraZeneca).
The FDA has postponed this meeting. The Committee meeting was scheduled to discuss the safety and efficacy of CT- P13, a proposed biosimilar to Janssen Biotech Inc.'s Remicade (infliximab), submitted by Celltrion, Inc. The FDA says that the reason for the postponement is that information requests are pending with the sponsor of the application. Tarius will monitor the Federal Register for announcements regarding this meeting.
Arthritis Advisory Committee (AAC)
AAC reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of arthritis, rheumatism, and related diseases, and makes appropriate recommendations to the Commissioner of Food and Drugs.