Etanercept Submitted for Chronic, Severe Plaque Psoriasis in Children
The U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application for etanercept (Enbrel) for treating pediatric patients with chronic, severe plaque psoriasis.1 The application was submitted in early January 2016 and is based on results of a one-year Phase 3 study with a five-year open-label extension that evaluated the safety and efficacy in pediatric patients with plaque psoriasis.
Explore this issueJune 2016
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The Prescription Drug User Fee Act (PDUFA) target action date for approval of this new indication is Nov. 5, 2016. If etanercept receives FDA approval, it will be the first systemic drug therapy approved in the U.S. to treat children with severe, chronic plaque psoriasis.
Novel Anti-RA Biologic Demonstrates Efficacy, Safety & Low Cost
Gerilimzumab is a novel anti-IL-6 cytokine antibody being used to treat inflammatory diseases, such as rheumatoid arthritis (RA).2 In two studies, gerilimzumab proved safe in very low doses of less than 50 mg (per patient per year) and infrequent dosing (one subcutaneous injection every eight weeks). These dosing levels may enable extremely low annual pricing—possibly as low as $2,000 per patient.
In one ascending dose study, gerilimzumab was administered at four dosages: 1 mg, 5 mg, 15 mg and 30 mg via subcutaneous injection. In a multiple-ascending dosing study, gerilimzumab was administered by subcutaneous injection at 5 and 20 mg doses, once monthly for three months. Both studies included 50 subjects and also evaluated safety and tolerability of gerilimzumab compared with placebo. In both studies, gerilimzumab was well tolerated, with no serious adverse events reported.
Gerilimzumab is expected to be submitted for a pivotal RA trial sometime this month (June 2016).
AXS-02 in a Phase 3 Clinical Trial for Knee OA
AXS-02 (disodium zoledronate tetrahydrate) is an osteoclast inhibitor currently in a Phase 3 clinical trial as a targeted, non-opioid oral therapy for managing chronic pain.3 Known as COAST-1 (Clinical Knee Osteoarthritis Symptom Treatment 1), the study is evaluating the safety and efficacy of disodium zoledronate tetrahydrate on pain in patients with knee osteoarthritis (OA).
Disodium zoledronate tetrahydrate has a high affinity for bone mineral and reduces osteoclast activity by inhibiting the farnesyl pyrophosphate synthase (FPPS) enzyme. The therapy is being developed to treat complex regional pain syndrome (CRPS) and knee OA pain associated with bone marrow lesions. It is also being investigated to treat chronic lower back pain.
Ixekizumab Receives FDA Approval for Plaque Psoriasis
Ixekizumab (Taltz) binds to interleukin (IL)-17A, suppressing inflammation. Ixekizumab is a humanized immunoglobulin G subclass 4 (IgG4) monoclonal antibody (mAb) with neutralizing activity against IL-17A. It has been approved by the FDA to treat adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.4 The treatment is available as an auto-injector and as a prefilled syringe.