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VBCR - April 2016, Vol 5, No 2 - FDA News & Updates

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FDA Approves Infliximab Biosimilar for Multiple Indications

Infliximab-dyyb (Inflectra; Cell­trion, Inc, Yeonsu-gu, Incheon, Korea) has been approved by the US Food and Drug Administration (FDA) for patients with chronic severe plaque psoriasis, and active ankylosing spondylitis or psoriatic arthritis, according to a recent announcement by the agency. The drug is also indicated for adults with moderate-to-severe active ulcerative colitis and inadequate response to standard therapy; in combination with methotrexate for patients with moderate-to-severe rheumatoid arthritis; and patients aged ≥6 years with moderate-to-severe Crohn’s disease and inadequate response to conventional therapy.

Infliximab-dyyb, which is administered via intravenous infusion, is a biosimilar to infliximab (Remicade; Janssen Biotech, Inc, Horsham, PA), and the second biosimilar to be approved by the FDA. Biosimilars can only be approved by the FDA if they demonstrate the strengths, mechanisms of action, routes of administration, and dosage forms of an already approved biological product. In terms of safety and effectiveness, biosimilars must not display clinically meaningful differences compared with the reference product. Biosimilars must also be created in facilities that meet FDA standards.

“Biosimilars can provide access to important treatment options for patients who need them,” explained Janet Woodcock, MD, Director, Center for Drug Evaluation and Research, FDA, Silver Spring, MD. “Patients and the health care community can be confident that biosimilar products are high quality and meet the agency’s rigorous scientific standards.” A review of evidence, including structural and functional characterization, and data pertaining to human pharmacokinetics, pharmacodynamics, clinical immunogenicity, animal studies, and clinical safety and effectiveness, demonstrating the biosimilarity of infliximab-dyyb to infliximab was the basis for the agency’s approval of the drug.

Respiratory infections, headaches, coughing, and stomach pain are among the most common side effects reported with infliximab-dyyb use. Reactions to infusions can occur ≤2 hours following an infusion, and may include symptoms such as rash and itching, shortness of breath, fever, chills, chest pain, and low or high blood pressure. Other possible side effects associated with infliximab-dyyb include liver injury, lupus-like syndrome, psoriasis, and, rarely, nervous system disorders.

This newly approved biosimilar includes a Boxed Warning alerting healthcare providers and patients to the increased risk for hospitalization- and death-inducing serious infections, including invasive fungal infections, bacterial sepsis, and tuberculosis. Lymphoma and other malignancies have also been reported in child and adolescent patients taking tumor necrosis factor blockers, which include infliximab products, and is also noted on the Boxed Warning. A patient medication guide that includes important information about uses and risks of the biosimilar must also be dispensed with it.

US Food and Drug Administration. FDA approves Inflectra, a biosimilar to Remicade. Updated April 5, 2016. Accessed April 6, 2016.

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Ixekizumab FDA Approved for Patients with Plaque Psoriasis

Ixekizumab (Taltz; Eli Lilly and Company, Indianapolis, IN) has been approved by the US Food and Drug Administration (FDA) in patients with moderate-to-severe plaque psoriasis, the agency has announced.

An autoimmune disorder and skin condition that results in patches of skin redness and flaking, psoriasis more commonly occurs in patients who have a family history of the disease. The condition primarily begins in people when they are aged 15 to 35 years, with the most common type—plaque psoriasis—associated with thick, red skin with silver, flaky scales.

Ixekizumab is an antibody that binds and inhibits the inflammatory response of the inflammation-causing interleukin-17A protein, and is intended for use in patients who are contenders for phototherapy, systemic therapy, or a combination of the 2 therapy types.

“[This] approval provides patients suffering from plaque psoriasis with another important treatment option to help relieve the skin irritation and discomfort from the condition,” explained Julie Beitz, MD, Director, Office of Drug Evaluation III, Center for Drug Evaluation and Research, FDA, in a press statement released by the agency.

Ixekizumab is administered by injection and was approved based on the safety and efficacy results of 3866 patients with plaque psoriasis who were candidates for systemic therapy or phototherapy and participated in 3 randomized, placebo-controlled clinical trials. Results from the 3 studies, which included assessment of the severity, extent, and nature of psoriatic skin changes, demonstrated ixekiz­umab’s greater clinical response with skin that was clear (or almost clear), compared with placebo.

Because ixekizumab impacts the immune system, approval of the drug includes a Medication Guide that informs patients they may have a greater risk for infection, or allergic or autoimmune conditions. Serious allergic reactions have been reported with this drug, as well as the emerging or worsening of inflammatory bowel disease; patients taking ixekizumab should be monitored for these conditions. Other side effects include reactions at the injection site, as well as upper respiratory and fungal infections.

US Food and Drug Administration. FDA approves new psoriasis drug Taltz. Updated March 23, 2016. Accessed March 28, 2016.

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First Once-Daily, Oral JAK Inhibitor Approved for Patients with RA

Tofacitinib citrate (Xeljanz XR extended-release tablets; Pfizer Inc, New York, NY) has been approved by the FDA for patients with moderate-to-severe rheumatoid arthritis (RA) who have inadequately responded or been intolerant to methotrexate, according to a news release by Pfizer Inc. The first, once-daily, oral treatment for this patient population, tofacitinib citrate is from the class of Janus kinase (JAK) inhibitors.

“The availability of Xeljanz XR provides physicians with a new treatment option for people with RA who may prefer an oral once-daily treatment,” stated Roy Fleischmann, MD, Clinical Professor, Department of Internal Medicine, The University of Texas Southwestern Medical Center, Dallas.

Tofacitinib citrate can be taken with or without methotrexate, and does not require injection or infusion. Side effects commonly associated with use of the drug include upper respiratory tract infections (eg, common cold, sinus infections), headaches, diarrhea, and nasopharyngitis.

Pfizer announces FDA approval of Xeljanz® XR (tofacitinib citrate) extended-release tablets, the first and only once-daily oral JAK inhibitor treatment for rheumatoid arthritis [news release]. New York City, NY; Pfizer Inc; February 24, 2016. www.pfiz itinib_citrate_extended_release_tablets_the_first_and_only_once_daily_oral_jak_inhibitor_treatment_for_rheumatoid_arthritis. Accessed March 28, 2016.

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Last modified: May 27, 2016
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