Breaking News
October 19, 2018 - Father’s exposure to nicotine may cause cognitive deficits in descendants
October 19, 2018 - Could we prevent Alzheimer’s disease by treating herpes?
October 19, 2018 - Nurse-led care can be more successful in managing gout
October 19, 2018 - Trump administration, pharma exchange verbal volleys on drug-price transparency
October 19, 2018 - Duke researchers find way to detect blood doping in athletes
October 19, 2018 - Many primary care doctors are still prescribing sedative drugs for older adults
October 19, 2018 - Finger length can predict sexuality in women say researchers
October 19, 2018 - Study finds differences in side-effects experienced by male and female OG cancer patients
October 19, 2018 - Few Seniors Who Self-Harm Referred for Mental Health Care
October 19, 2018 - Don’t sweat the sweet stuff
October 19, 2018 - URMC researchers discover new approach to deliver therapeutics to the brain
October 19, 2018 - Middlemen suppliers can increase drug prices and hospital bills, say Johns Hopkins researchers
October 19, 2018 - $11 million NIH grant for Clemson University helps launch new center for musculoskeletal research
October 19, 2018 - A new approach identified to control Zika virus, dengue fever
October 19, 2018 - Head Blows Without Concussion May Not Damage Brain, Study Claims
October 19, 2018 - US opioid use not declined, despite focus on abuse and awareness of risk
October 19, 2018 - Next-generation RNA sequencing technology sheds new light on human mitochondrial diseases
October 19, 2018 - UT Southwestern biochemist receives 2019 Breakthrough Prize in Life Sciences for innate immunity discovery
October 19, 2018 - The immune system also plays a key role in day-to-day function of healthy organs
October 19, 2018 - New tool may reveal how the brain structure impacts brain activity, human behavior
October 19, 2018 - Trump Administration announces ‘Winning on Reducing Food Waste’ initiative
October 19, 2018 - For-profit nursing home residents more likely to experience health issues caused by substandard care
October 19, 2018 - Incidence of stroke has risen steadily among marijuana users, show studies
October 19, 2018 - Conceptual framework proposed to examine role of exercise in multiple sclerosis
October 19, 2018 - Near infrared spectroscopy technique for accurate evaluation of chondral injuries
October 19, 2018 - Scientists receive $5.1 million grant to develop stem cell-based therapy for blinding retinal conditions
October 19, 2018 - Shorter physician encounters associated with antibiotic prescribing
October 19, 2018 - In the Spotlight: Enjoying research and exploring opportunities
October 19, 2018 - Physical activity lowers cardiovascular mortality risk in frail older adults
October 19, 2018 - New imaging tool helps visualize how sound-induced vibrations travel through the ear
October 19, 2018 - Key insights into the application, production of bioactive materials
October 19, 2018 - New urea sorbent could speed up the development of wearable artificial kidney
October 19, 2018 - Intensive care patients’ muscles less able to use fats for energy
October 19, 2018 - FDA Advisory Committee Recommends Approval of Dsuvia for the Treatment of Moderate-to-Severe Acute Pain
October 19, 2018 - 48,XXXY syndrome – Genetics Home Reference
October 19, 2018 - Physical exercise improves the elimination of toxic proteins from muscles
October 19, 2018 - How a new system improved wait times for Stanford kidney transplant patients
October 19, 2018 - Nutrition has bigger positive impact on bone mass and strength than exercise
October 19, 2018 - Study finds lack of progress in media representation of nurses over last 20 years
October 19, 2018 - Many people have trouble understanding differences between OCD and OCPD
October 19, 2018 - New family planning app found to be as effective as modern methods
October 19, 2018 - Gastric Banding, Metformin Similar for Improving Glycemia
October 19, 2018 - Physiologist publishes findings on the role of the protein titin in muscle contraction
October 19, 2018 - What digital health companies need to do to succeed
October 19, 2018 - N. Carolina Sees Alarming Spike in Heart Infections Among Opioid Users
October 19, 2018 - Video monitoring of TB therapy works well in urban and rural areas
October 19, 2018 - Determining acid-neutralizing capacity for OTC antacids
October 19, 2018 - Males who spend more time taking care of kids have greater reproductive success
October 18, 2018 - Study to explore bioethics of brain organoids
October 18, 2018 - Environmental conditions may drive development of multiple sclerosis
October 18, 2018 - Genetically modifying zebrafish provides more accurate disease models
October 18, 2018 - Purdue Pharma, Eisai announce positive topline results from Phase 3 study of lemborexant
October 18, 2018 - 5 Strength-Training Mistakes to Avoid
October 18, 2018 - Immune system’s balancing act keeps bowel disease in check
October 18, 2018 - Anti-inflammatory drug effective for treating lymphedema symptoms | News Center
October 18, 2018 - Keeping Your Voice Young
October 18, 2018 - One-time universal screening recommended to tackle increase in hepatitis C
October 18, 2018 - Researchers to develop new stem cell-based strategies for treating vision disorders
October 18, 2018 - Detecting epigenetic signature may help people stay ahead of inflammatory bowel disease
October 18, 2018 - Understanding AFib: Slowing down the dancing heart
October 18, 2018 - Using NMR to Reduce Fraud
October 18, 2018 - New automated model identifies dense breast tissue in mammograms
October 18, 2018 - Mysterious polio-like illness baffles medical experts while frightening parents
October 18, 2018 - Cases of Acute Flaccid Myelitis on the rise across U.S.
October 18, 2018 - Dietary fiber reduces brain inflammation during aging
October 18, 2018 - New tool could help prioritize recovery efforts for the poorest hit by natural disasters
October 18, 2018 - Hundreds of dietary supplements shown to contain unapproved drugs
October 18, 2018 - Active Pharmaceuticals ID’d in >700 Dietary Supplements
October 18, 2018 - Cell death protein also damps inflammation
October 18, 2018 - AI pathology diagnostic tool developed using deep learning technology from Olympus
October 18, 2018 - Health Highlights: Oct. 15, 2018
October 18, 2018 - Largest study of ‘post-treatment controllers’ reveals clues about HIV remission
October 18, 2018 - Bad Blood in Silicon Valley: A conversation with John Carreyrou
October 18, 2018 - ANTRUK’s Annual Lecture sends out message on shortage of funds for antibiotic research
October 18, 2018 - NAM special publication outlines steps to ensure interoperability of health care systems
October 18, 2018 - Novel method uses just a drop of blood to monitor effect of lung cancer therapy
October 18, 2018 - New blood test could spare cancer patients from unnecessary chemotherapy
October 18, 2018 - Training young researchers to work with data volumes arising in the health sector
October 18, 2018 - New Metrohm IC method is reliable and convenient to use for zinc oxide assay
October 18, 2018 - Global AIDS, TB fight needs more money: health fund
CHMP recommends approval of Gilenya for treatment of multiple sclerosis in children, adolescents

CHMP recommends approval of Gilenya for treatment of multiple sclerosis in children, adolescents

image_pdfDownload PDFimage_print

Novartis today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Gilenya® (fingolimod) for the treatment of children and adolescents 10 to 17 years of age with relapsing remitting forms of multiple sclerosis (RRMS). If approved, Gilenya® is expected to be the first oral disease-modifying therapy indicated for these patients based on a randomized controlled clinical study[1]. The younger patient population experiences two-to-three times as many relapses as adults, often leading to a more severe prognosis and earlier disability compared to adult-onset MS[2].  If approved, Gilenya would address the urgent need faced by these young people. This market authorization would expand the age range of Gilenya, one of the most prescribed MS treatments worldwide. Gilenya was previously approved for adults with RRMS aged 18 years and older in Europe.

“The lives of kids are immensely impacted by the early onset of MS, from playing sports, going to school or enjoying time with friends and family. We need to address the urgent need for new and effective treatments, and with Gilenya, we may now have an option that can make a substantial difference for young patients”, said Paul Hudson, Chief Executive Officer, Novartis Pharmaceuticals. “This CHMP positive opinion is a testament to our relentless dedication to reimagining MS care across all generations. We are very excited to be a step closer to bringing this much-needed treatment to young MS patients across Europe.”

“Today’s CHMP positive opinion is a momentous advancement for the children and adolescents impacted by MS,” said Pedro Carrascal, President, European Multiple Sclerosis Platform. “Young European patients and their families, who have long been hoping for an effective disease modifying therapy, could soon have a new treatment option to alleviate the devastating impact of this condition.”

The CHMP positive opinion is based on the PARADIGMS trial, a first-of-its-kind clinical study in MS specifically designed for children and adolescents aged 10 to 17 years[3]. Results from the double-blind, randomized, multi-center Phase III study of Gilenya vs. interferon beta-1a show that compared to interferon beta-1a, Gilenya significantly reduced the annualized relapse rates by 82% (relative difference to interferon beta-1a, p<0.001) and delayed the time to first relapse[4]. Furthermore, it also significantly reduced the number of new or newly enlarged T2 lesions up to 24 months by 53% (p<0.001) and the annualized rate of brain volume loss (brain shrinkage) by 40%[4]. The full PARADIGMS data was recently published in The New England Journal of Medicine.

The European Commission will review the CHMP opinion and is expected to deliver its final decision within three months. The decision will be applicable to all 28 European Union member states plus Iceland, Norway and Liechtenstein. Gilenya received FDA approval for the treatment of children and adolescents 10 years of age and older with MS on May 11, 2018.

Source:

https://www.novartis.com/

Posted in: Child Health News | Drug Trial News | Medical Condition News

Tags: Adolescents, Antibody, Brain, Central Nervous System, Children, Clinical Trial, Disability, Extavia, Fingolimod, Frequency, Gadolinium, Gilenya, Health Care, Immune System, Inflammation, Manufacturing, Monoclonal Antibody, Multiple Sclerosis, Nervous System, Pharmaceuticals, Research, Sclerosis

Tagged with:

About author

Related Articles