CSL Behring, Leader in Rare Diseases, Showcases Innovations in Neuromuscular Medicine (NMM) at the 2018 American Academy of Neurology Annual Meeting
CSL Behring, Leader in Rare Diseases, Showcases Innovations in Neuromuscular Medicine (NMM) at the 2018 American Academy of Neurology Annual Meeting - CSL Behring will host an industry therapeutic update highlighting findings from the PATH trial, the largest clinical trial in CIDP, and present key poster presentations featuring advances in the field of NMM |
[20-April-2018] |
KING OF PRUSSIA, Pa., April 20, 2018 /PRNewswire/ -- Global biotherapeutics leader CSL Behring today announced that it will host an Industry Therapeutic Update at the 2018 annual meeting of the American Academy of Neurology (AAN) which will focus on neuromuscular medical research from the PATH (Polyneuropathy and Treatment with Hizentra) study, the largest ever CIDP trial. In addition, CSL Behring will support two scientific poster presentations and host an exhibit booth, #846, where attendees will have the opportunity to go through a simulation to understand some common CIDP symptoms from a patient perspective.
"CSL Behring has a long history in delivering on its promise to develop immunoglobulin replacement therapies that treat rare conditions related to the immune system and we are committed to bringing those treatments to neurologists," said Debra Bensen-Kennedy, MD, Vice President for Medical Affairs, North America, CSL Behring. "Our significant presence at this year's AAN meeting signals our formal entry into the field of Neurology in the US, with a specific focus on neuromuscular medicine." During Monday's Industry Therapeutic Update, "A PATH FORWARD IN PERIPHERAL NEUROIMMUNOLOGY: A Subcutaneous Alternative for Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)" (April 23, 7 p.m. PDT, Orpheum Ballroom, Hotel Indigo Los Angeles) leading expert Ericka Simpson, M.D., will share highlights from the PATH study. She will be joined by Chafic Karam, M.D., and CIDP patient and advocate Elizabeth Thirtyacre as they share their experiences with the CIDP patient journey and treatment approach. The program will also include a live demonstration of a subcutaneous infusion by infusion science specialist Melody Bullock, BS, BSN, MS, IgCN, CRNI. Posters summarizing research supported by CSL Behring will be presented during the meeting, including:
About CIDP About Hizentra® Important Safety Information for the U.S.
For subcutaneous infusion only.
Hizentra is contraindicated in patients with a history of anaphylactic or severe systemic reaction to human immune globulin (Ig) or components of Hizentra (eg, polysorbate 80), as well as in patients with immunoglobulin A deficiency with antibodies against IgA and a history of hypersensitivity. Because Hizentra contains L-proline as stabilizer, use in patients with hyperprolinemia is contraindicated. IgA-deficient patients with anti-IgA antibodies are at greater risk of severe hypersensitivity and anaphylactic reactions. Thrombosis may occur following treatment with Ig products, including Hizentra. Monitor patients for aseptic meningitis syndrome (AMS), which may occur following treatment with Ig products, including Hizentra. In patients at risk of acute renal failure, monitor renal function, including blood urea nitrogen, serum creatinine and urine output. In addition, monitor patients for clinical signs of hemolysis or pulmonary adverse reactions (eg, transfusion-related acute lung injury [TRALI]). Hizentra is derived from human blood. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent and its variant (vCJD), cannot be completely eliminated. The most common adverse reactions (observed in ≥5% of study subjects) were local infusion-site reactions, as well as headache, diarrhea, fatigue, back pain, nausea, extremity pain, cough, upper respiratory tract infection, rash, pruritus, vomiting, upper abdominal pain, migraine, arthralgia, pain, fall, and nasopharyngitis. The passive transfer of antibodies can interfere with response to live virus vaccines and lead to misinterpretation of serologic test results. Full Hizentra prescribing information can be found at http://labeling.cslbehring.com/PI/US/Hizentra/EN/Hizentra-Prescribing-Information.pdf. About Privigen® Important Safety Information for the U.S.
WARNING: THROMBOSIS, RENAL DYSFUNCTION AND ACUTE RENAL FAILURE
See full prescribing information for complete boxed warning. In patients at risk of developing acute renal failure, monitor urine output and renal function, including blood urea nitrogen and serum creatinine. Hyperproteinemia, increased serum viscosity, or hyponatremia can occur with Privigen. Infrequently, aseptic meningitis syndrome (AMS) may occur—especially with high doses or rapid infusion. Hemolysis, either intravascular or due to enhanced red blood cell sequestration, may occur. Risk factors include non-O blood group and high doses. Closely monitor patients for hemolysis and hemolytic anemia. During and shortly following Privigen infusion, elevations of systolic and diastolic blood pressure (including cases of hypertensive urgency) have been observed. These elevations resolved or significantly improved within hours with oral anti-hypertensive therapy or observation alone. Check patients for a history of hypertension and monitor blood pressure during this period. Consider relative risks and benefits before prescribing high-dose regimen for chronic ITP and CIDP in patients at increased risk of thrombosis, hemolysis, acute kidney injury or volume overload. Monitor patients for pulmonary adverse reactions (transfusion-related acute lung injury [TRALI]). Privigen is derived from human plasma. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent and its variant (vCJD), cannot be completely eliminated. In clinical studies of patients with PI, the most common adverse reactions to Privigen, observed in >5% of subjects, were headache, fatigue, nausea, chills, vomiting, back pain, pain, elevated body temperature, abdominal pain, diarrhea, cough, stomach discomfort, chest pain, joint swelling/effusion, influenza-like illness, pharyngolaryngeal pain, urticaria, and dizziness. Serious adverse reactions were hypersensitivity, chills, fatigue, dizziness, and increased body temperature. In clinical studies of patients being treated for chronic ITP, the most common adverse reactions, seen in >5% of subjects, were laboratory findings consistent with hemolysis, headache, elevated body temperature, anemia, nausea, and vomiting. A serious adverse reaction was aseptic meningitis syndrome. In clinical studies of patients being treated for CIDP, the most common reactions, observed in >5% of subjects, were headache, asthenia, hypertension, nausea, pain in extremity, hemolysis, influenza-like illness, leukopenia, and rash. Serious adverse reactions were hemolysis, exacerbation of CIDP, acute rash, increased diastolic blood pressure, hypersensitivity, pulmonary embolism, respiratory failure, and migraine. Treatment with Privigen might interfere with a patient's response to live virus vaccines and could lead to misinterpretation of serologic testing. In patients over 65 and those at risk of renal insufficiency, do not exceed recommended dose and infuse at the minimum rate practicable. Full Privigen prescribing information, including the complete boxed warning, can be found at http://www.privigen.com/prescribing-information. About CSL Behring CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. The parent company, CSL Limited (ASX:CSL), headquartered in Melbourne, Australia, employs nearly 20,000 people, delivering its life-saving therapies to people in more than 60 countries. For more information visit www.cslbehring.com and follow us on www.Twitter.com/CSLBehring. i Laughlin R.S. et al. Incidence and prevalence of CIDP and the association of diabetes mellitus. Neurology. 7;73(1):39-45.
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