Here’s a brief look at medications for rheumatologic disorders that were newly approved in the last quarter of 2017.
The fourth quarter of 2017 saw a spike in new drug approvals from the FDA.
Here’s a brief overview of agents for rheumatology that have been newly approved or that were granted a new indication.
The FDA has approved Xeljanz and Xeljanz XR (tofacitinib) for the treatment of adult patients with active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to methotrexate or other disease-modifying antirheumatic drugs. Xeljanz/Xeljanz XR is the first and only Janus kinase inhibitor with approved indications for both moderate to severe rheumatoid arthritis and active PsA. The FDA approval of tofacitinib for the treatment of adults with active PsA was based on data from the phase 3 Oral Psoriatic Arthritis Trial (OPAL) clinical development program, which consisted of 2 pivotal studies, OPAL Broaden and OPAL Beyond, as well as available data from an ongoing long-term extension trial, OPAL Balance. (Approved 12/14/17, Pfizer Inc.)
Nucala (mepolizumab) is the first drug approved by the FDA specifically to treat adult patients with eosinophilic granulomatosis with polyangiitis (EGPA). According to the NIH, EGPA (formerly known as the Churg-Strauss syndrome) affects 10.7 to 14 per 1,000,000 adults. The expanded indication of Nucala meets a critical, previously unmet need for these patients. (Approved 12/12/17, GlaxoSmithKline)
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The FDA has approved Taltz (ixekizumab) injection 80 mg/mL for the treatment of adults with active psoriatic arthritis. Taltz was first approved by the FDA in March 2016 for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. (Approved 12/1/17, Eli Lilly and Company)
Simponi Aria (golimumab), the only fully-human anti-tumor necrosis factor (TNF)-alpha therapy administered via a 30-minute infusion, has received approval from the FDA for the treatment of adults with active psoriatic arthritis or active ankylosing spondylitis. The approvals for these indications follow the first FDA approval of Simponi Aria in 2013 for the treatment of moderately to severely active rheumatoid arthritis. (Approved 10/20/17, Janssen Biotech, Inc.)
The FDA has approved Zilretta (triamcinolone acetonide extended-release injectable suspension), the first and only extended-release, intra-articular injection for OA knee pain. The product provides a new non-opioid therapy that may help patients manage their OA pain for over 12 weeks via its proprietary microsphere technology. Zilretta’s label also includes results from a double-blind, randomized, parallel-group trial, which examined blood glucose concentrations in patients with T2 diabetes. That trial showed that Zilretta may avoid disruptive blood glucose spikes that can occur with corticosteroid use in patients with knee OA and T2 diabetes. (Approved 10/6/17, Flexion Therapeutics, Inc.)