FDA
14th November 2013

AdComm Roll Call Special – Spotlight on: Arthritis Advisory Committee

The Arthritis Advisory Committee (AAC) has the responsibility of reviewing and evaluating data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of arthritis, rheumatism, and related diseases.

AdComm Roll Call Special – Spotlight on: Arthritis Advisory Committee

The Arthritis Advisory Committee (AAC) has the responsibility of reviewing and evaluating data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of arthritis, rheumatism, and related diseases. Based on this evaluation, the committee makes appropriate recommendations to the Commissioner of Food and Drugs regarding the future of that drug in the market.

There are several kinds of drugs reviewed by the AAC including, but not limited to, disease-modifying antirheumatic drugs (DMARDs), biologics, analgesics, corticosteroids and nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs are arguably the largest and most widely used drug class in the world for a variety of applications. Every major pharmaceutical manufacturer in the world markets drugs that reduce inflammation by inhibiting the prostaglandin pathway, including well-known brands such as the following: Motrin (ibuprofen), Naprosyn (naproxen), and Voltaren (diclofenac). Recently, NSAIDs have been scrutinized based on research suggesting that they have a greater risk of cardiovascular events than what was once thought.

So far this year, AAC has met twice. The first meeting consisted of an assessment of the SpondyloArthritis international Society (ASAS) classification criteria for axial spondyloarthritis and the implications of using these criteria for drug approval. The second meeting discussed the supplemental biologic license application (sBLA) 125057 for Humira (adalimumab) injection, submitted by AbbVie Inc.

In the United States, Humira (adalimumab) is currently approved for treatment of rheumatoid arthritis, plaque psoriasis, ulcerative colitis, ankylosing spondylitis and psoriatic arthritis. In July, the AAC rejected the bid to gain approval for Humira (submitted by AbbVie) for treatment of active nonradiographic axial spondyloarthritis in adults with signs of inflammation by elevated CRP or MRI. The panel voted 12-1 with one abstention. Additionally, the AAC split 7-6 with one abstention when surveyed about recommending approval of UCB’s Cimzia (certolizumab) for treatment of active axial spondyloarthritis, including ankylosing spondylitis (AS). In both cases, the panel expressed uncertainty regarding the loose definition of nonradiographic ax-SpA (nr-axSpA) and whether each of the respective manufacturers had provided sufficient evidence to support licensure in that patient subgroup. Both biologic drugs are associated with adverse effects such as serious infections. The panelists cautioned that in this area of treatment, these drugs have the potential to be inappropriately prescribed for people who actually have mechanical, rather than inflammatory, back pain. 

The Committee consists of 11 core voting members including the Chair. Presently, the Chair position for the AAC is vacant. Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of arthritis, rheumatology, orthopedics, epidemiology or statistics, analgesics, and related specialties. In addition to the voting members, the Committee may include one non-voting member who is identified with industry interests. Please click HERE for a list of individuals currently on the AAC roster.

Preparing for an AAC meeting? Learn more about ISS’ Strategic Approach to Advisory Committee Prep! 

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