Breaking News
April 21, 2018 - Americans world’s biggest TV addicts, watching four hours a day
April 21, 2018 - Investigational drug may help increase protein levels in babies with spinal muscular atrophy
April 21, 2018 - Study shows distinctions between age groups in predicting and responding to stress at home
April 21, 2018 - Aziyo Biologics, BIOTRONIK enter into US co-distribution agreement
April 21, 2018 - Opiate Use Linked to Early Mortality in IBD Patients
April 21, 2018 - Online ads help pregnant smokers quit
April 21, 2018 - Opioid pain medications may not be safe for hemodialysis patients
April 21, 2018 - Rare variants in non-coding DNA inherited from parents heighten autism risk
April 21, 2018 - A needleless glucose monitor for diabetes patients
April 21, 2018 - BD introduces new informatics and automation solutions for clinical laboratories
April 21, 2018 - Turn Chores Into a Fitness Routine
April 21, 2018 - DNA methylation plays key role in stem cell differentiation
April 21, 2018 - Scientists find link between soil metals and cancer mortality
April 21, 2018 - Experts discuss implications of low calcium intake in global population
April 21, 2018 - GNA Biosolutions to display Pharos V8 Laser PCR instrument at Analytica trade fair
April 21, 2018 - People with vitamin D deficiency may be at greater risk of diabetes
April 21, 2018 - Study findings could open new possibilities for treating cancer with adenovirus
April 21, 2018 - People who use medical marijuana have higher rates of prescription drug use, study finds
April 21, 2018 - Study debunks ‘myth’ that strenuous exercise dampens immunity
April 21, 2018 - FDA approves marijuana based medication for epilepsy treatment
April 21, 2018 - Researchers find novel genes for longevity in mammals
April 21, 2018 - GNA Biosolutions and project partners launch new research project to develop TB diagnostic platform for POC applications
April 21, 2018 - Scientists identify gene responsible for evolution of recombination rates
April 21, 2018 - UConn researchers develop new composite for healing broken load-bearing bones
April 21, 2018 - Study challenges use of whole-brain radiation for small-cell lung cancer patients with brain metastases
April 21, 2018 - People who become physically active after heart attack more likely to live longer, shows research
April 21, 2018 - CPRIT awards $2 million grant to push forward breast cancer research in West Texas
April 21, 2018 - Unhealthy diet damages the development of immature fat cells, study shows
April 21, 2018 - Consumption of protein supplements with meals may provide better weight control
April 21, 2018 - 4 Types of Foods to Help Boost Your Memory
April 21, 2018 - How did gonorrhea become a drug-resistant superbug?
April 21, 2018 - DePuy Synthes announces clinical results related to use of CORAIL Hip System Femoral Stems
April 21, 2018 - New initiative launched to support goals of Human Cell Atlas
April 20, 2018 - Teen patient gets a new lease on life
April 20, 2018 - Cancer Australia launches new framework to improve outcomes for lung cancer patients
April 20, 2018 - ‘Gut-on-a-chip’ model recreates intestinal matrix critical for nutrient absorption
April 20, 2018 - Researchers develop new drug-testing platform for epilepsy
April 20, 2018 - FDA Alert: NxtGen Botanicals Maeng Da Kratom by NGB Corp.: Recall
April 20, 2018 - Pelizaeus-Merzbacher-like disease type 1 – Genetics Home Reference
April 20, 2018 - Tick-borne diseases reach epidemic levels, panel says
April 20, 2018 - A potential “male pill” without side effects
April 20, 2018 - Researchers discover new information related to rare form of leukemia
April 20, 2018 - Researchers find crucial links between dopamine and avoidance behavior
April 20, 2018 - UGA scientist creates system for efficient detection of foodborne pathogens
April 20, 2018 - Social Support of Autonomy Tied to Better Glycemic Control in DM
April 20, 2018 - Study reports use of nutritional ketosis with mobile app intervention could reverse Type 2 diabetes
April 20, 2018 - New microscopy techniques allow quasi-biochemical studies on living T cells
April 20, 2018 - Study shows connection between muscular strength and brain health
April 20, 2018 - Ecolab introduces Life Sciences cleanroom program in North America
April 20, 2018 - Normal weight people with fat belly may have more chance of heart problems
April 20, 2018 - Male fruit flies like sex and alcohol
April 20, 2018 - Meditation could help reduce anxiety levels and some heart health risk factors
April 20, 2018 - Improving job prospects unlikely to control opioid epidemic
April 20, 2018 - Skin Sensor Might Someday Track Alcoholics’ Booze Intake
April 20, 2018 - The relevance of GABA for diabetes highlighted in two new studies
April 20, 2018 - Novel method enables fast and noninvasive assessment of tumor status
April 20, 2018 - IU psychologist receives NIH grant to study earliest phases of language learning in children
April 20, 2018 - Walking fast lowers risk of hospitalization in heart patients, shows study
April 20, 2018 - Study reveals surprising insights into RNA-binding proteins
April 20, 2018 - Young victims of cyberbullying twice as likely to attempt suicide and enact suicidal behavior
April 20, 2018 - Role of UBE3A enzyme in Angelman syndrome
April 20, 2018 - NovaDigm Therapeutics initiates NDV-3A Phase 2a study for reduction of S. aureus in military trainees
April 20, 2018 - High-tech microscope reveals how cancer-causing virus anchors itself to human DNA
April 20, 2018 - Experimental compound reduces destructive inflammation to improve stroke outcome
April 20, 2018 - The May issue of Drug Discovery Today is a Special Issue and will be published very soon
April 20, 2018 - Larger families linked to heightened tooth loss risk for moms
April 20, 2018 - Scientists develop tiny fluorescent probe that seeks out GLUT5 and detects cancer cells
April 20, 2018 - The Swedish Childhood Cancer Foundation awards grant to KI researchers
April 20, 2018 - AMSBIO’s MC-Easy minicircle technology allows sustained transgene expression in quiescent cells and tissues
April 20, 2018 - Researchers use optogenetics to treat chronic pain
April 20, 2018 - Discovery of 100 new genes may aid research into pigmentation
April 20, 2018 - AYOXXA introduces new LUNARIS Mouse 12-Plex Th17 Kit for quantitative analysis of Th17 cell biology
April 20, 2018 - Compound derived from immune cells treats psoriasis in mice
April 20, 2018 - GABA-transaminase deficiency – Genetics Home Reference
April 20, 2018 - Key heart risks decline for older Americans
April 20, 2018 - UD professor wins $2.3 million grant from NIH for research on Achilles tendinopathy
April 20, 2018 - Researchers discover unique protein in malaria parasite that could be new drug target
April 20, 2018 - Bio-Techne expands automation capabilities of popular RNAscope ISH technology
April 20, 2018 - Smartphone app effective in promoting proper child car seat practices
April 20, 2018 - Nutraceuticals could play an important role in preventing heart disease
FDA Approves Hizentra (Immune Globulin Subcutaneous [Human] 20% Liquid) for the Treatment of Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

FDA Approves Hizentra (Immune Globulin Subcutaneous [Human] 20% Liquid) for the Treatment of Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

image_pdfDownload PDFimage_print

KING OF PRUSSIA, Pa. – March 16, 2018 – Global biotherapeutics leader CSL Behring today announced that the U.S. Food and Drug Administration (FDA) approved Hizentra (Immune Globulin Subcutaneous [Human] 20% Liquid) as the first and only subcutaneous immunoglobulin (SCIg) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent relapse of neuromuscular disability and impairment. The approval was based on data from the Phase III PATH (Polyneuropathy And Treatment with Hizentra) study, which is the largest controlled clinical study in CIDP patients to date. CIDP is a rare autoimmune disorder that affects the peripheral nerves and may cause permanent nerve damage.

“This new FDA approval for Hizentra marks a pivotal milestone for patients struggling with the disabling neurological effects of CIDP,” said Dr. Andrew Cuthbertson, Chief Scientific Officer and R&D Director, CSL Limited. “As the first and only subcutaneous immunoglobulin therapy approved to treat CIDP, and studied in the largest controlled clinical trial for CIDP, Hizentra offers patients a more convenient treatment option with proven efficacy and the flexibility and freedom to self-infuse at home. CSL Behring is deeply committed to delivering innovative therapies to patients with rare and serious diseases like CIDP, and today we are proud to now offer a portfolio of immunoglobulin therapies for CIDP.”

The PATH study demonstrated that the percentage of patients experiencing CIDP relapse or withdrawal for any other reason during SCIg treatment was significantly lower with Hizentra (38.6 percent on low-dose Hizentra [0.2 g/kg weekly]; 32.8 percent on high-dose Hizentra [0.4 g/kg weekly]; p values = 0.007 and <0.001 respectively) than with placebo (63.2 percent). Additionally, the PATH study demonstrated that patients on Hizentra reported fewer systemic adverse reactions (ARs) per infusion compared to IVIg treatment (2.7 percent versus 9.8 percent, respectively). In fact, 93 percent of the 4,225 total Hizentra infusions were free of any ARs.

“As a practicing neurologist treating patients with CIDP, I am excited to have a safe and effective subcutaneous treatment option to offer my patients who are interested in more treatment flexibility and control in their busy lives,” said Dr. Todd Levine, Phoenix Neurological Associates.

In CIDP, the myelin sheath, or the protective covering of the nerves, is damaged, which may result in numbness or tingling, muscle weakness, fatigue, and other symptoms. The effects of CIDP can worsen over time, leading to significant activity limitations and a decreased quality of life. Approximately 30 percent of CIDP patients will progress to wheelchair dependence if not treated.

“Despite available treatment options, many CIDP patients continue to struggle with daily disease and lifestyle challenges, making continued research and innovation critical,” said Lisa Butler, executive director of the GBS|CIDP Foundation International. “The approval of Hizentra offers patients who were once burdened by traveling to the infusion center or hospital the flexibility to self-administer their treatment at a time, place, and on a schedule that’s convenient for them.”

Hizentra is currently approved in 51 countries for the treatment of certain immune deficiencies. For more information about Hizentra, including the U.S. prescribing information, visit www.hizentra.com.

About CIDP

In CIDP, a rare autoimmune disorder that affects the peripheral nerves (those outside the brain and spinal cord), the myelin sheath, the protective covering of the nerves, is damaged. This may result in numbness or tingling, muscle weakness, fatigue, and other symptoms. CIDP effects can worsen over time, leading to significant activity limitations and a decreased quality of life. CIDP can occur at any age and is more common in men than in women. Approximately 30 percent of CIDP patients will progress to wheelchair dependence if not treated. In the U.S., it is estimated that the incidence of CIDP is up to two patients per 100,000 people each year,[i] with a prevalence of 40,000 people affected.[ii]

About Hizentra

Hizentra (Immune Globulin Subcutaneous [Human] 20% Liquid), the first 20 percent SCIg developed for subcutaneous use, is registered in over 51 countries and approved to treat certain immune deficiencies. Hizentra, the world’s most prescribed SCIg, has a proven track record of safety, efficacy, and tolerability and has over 4.8 million exposures worldwide since 2010.

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by its promise to save lives. Focused on serving patients’ needs by using the latest technologies, we develop and deliver innovative therapies that are used to treat coagulation disorders, primary immune deficiencies, hereditary angioedema, inherited respiratory disease, and neurological disorders. The company’s products are also used in cardiac surgery, organ transplantation, burn treatment, and to prevent hemolytic disease of the newborn.

CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. The parent company, CSL Limited (ASX:CSL; USOTC:CSLLY), headquartered in Melbourne, Australia, employs nearly 20,000 people, and delivers 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.

[ii] American Association of Neuromuscular & Electrodiagnostic Medicine (2017). Chronic Inflammatory Demyelinating Polyneuropathy. http://www.aanem.org/Patients/Disorders/Chronic-Inflammatory-Demyelinating-Polyneuropathy. Accessed March 2018.

Source: CSL Behring

Posted: March 2018

Related Articles:

Hizentra (immune globulin subcutaneous (human)) FDA Approval History

Tagged with:

About author

Related Articles