Breaking News
October 17, 2018 - Modeling Non-Numerical Data in Systems Biology
October 17, 2018 - Research aims to address health disparities in African-American men
October 17, 2018 - Human and cattle decoys trap outdoor-biting mosquitoes in malaria endemic regions
October 17, 2018 - High Circulating Prolactin Level Inversely Linked to T2DM Risk
October 17, 2018 - Study finds gene variant predisposes people to both Type 2 diabetes and low body weight
October 17, 2018 - Network of doctors identify the cause of 31 new conditions
October 17, 2018 - Notable improvement in brain cancer survival among younger patients but not much for elderly
October 17, 2018 - Scientists shed light on roles of transcription factors, TP63 and SOX2, in squamous cell carcinoma
October 17, 2018 - Costs of Medicare Diabetes Prevention Program may be higher than expected reimbursement
October 17, 2018 - Misuse of prescription opioids or benzodiazepines associated with suicidal thoughts
October 17, 2018 - New research seeks to address sex disparities in women’s health
October 17, 2018 - C-Section Rates Have Nearly Doubled Since 2000: Study
October 17, 2018 - Talking to Your Kids About STDs
October 17, 2018 - New classification of periodontal and peri-implant diseases and conditions
October 17, 2018 - Herbert D. Kleber, Pioneer in Addiction Treatment, Dies at 84
October 17, 2018 - Health effects of smoke-filled atmosphere
October 17, 2018 - Down syndrome may hold important clues to onset of Alzheimer’s disease
October 17, 2018 - A special report on US’ aging societies
October 17, 2018 - Birth mode may have acute effects on neurodevelopment, study suggests
October 17, 2018 - Global health innovation system fails to deliver affordable treatments to patients, says report
October 17, 2018 - Simple, inexpensive test quickly detects antibiotic-resistant ‘superbugs’
October 17, 2018 - New drugs could reduce risk of heart disease when added to statins
October 17, 2018 - Visible and valued: Stanford Medicine’s first-ever LGBTQ+ Forum
October 17, 2018 - HVP vaccination not linked with rise in teen risky sex
October 17, 2018 - Potential ‘early warning markers’ for sepsis discovered
October 17, 2018 - Who knew? Life begins (again) at 65
October 17, 2018 - Application of blood pressure guidelines ups treatment
October 17, 2018 - Stanford researchers find that small molecule may help treat enzyme deficiency
October 17, 2018 - Speed Cameras Save Money and Lives in New York City
October 17, 2018 - Men who conform to ‘the man box’ more likely to consider suicide and violence
October 17, 2018 - Researchers aim to create more authentic organoids for drug testing, transplantation
October 16, 2018 - New blood test for pediatric brain tumor patients offers safer approach than surgical biopsies
October 16, 2018 - Age-related estrogen increase may be the culprit behind inguinal hernias in men
October 16, 2018 - Skills-Based Intervention Did Not Cut Systolic BP After Stroke, TIA
October 16, 2018 - Researchers uncover new role of TIP60 protein in controlling tumour formation
October 16, 2018 - Behind the scenes of a lifesaving heart surgery
October 16, 2018 - ‘To See the Suffering’
October 16, 2018 - Drinking concentrated rosemary extract can boost memory by up to 15%, shows research
October 16, 2018 - Medicare Advantage riding high as new insurers flock to sell to seniors
October 16, 2018 - NHS tackles prescription fraud to save millions
October 16, 2018 - New molecular switch may help develop sophisticated photomedications
October 16, 2018 - Improving access to behavioral health screenings for pregnant and postpartum women
October 16, 2018 - Health Highlights: Oct. 12, 2018
October 16, 2018 - Study holds promise for new pediatric brain tumor treatment
October 16, 2018 - Patient advocate uses MRI scans to create art and spark conversations about life with illness
October 16, 2018 - Fish oil based diets may suppress growth and spread of breast cancer cells
October 16, 2018 - Number of VHA facilities offering acupuncture has increased rapidly
October 16, 2018 - Influential Leapfrog Group jumps in to rate 5,600 surgery centers
October 16, 2018 - HIV-infected infants more likely to acquire congenital cytomegalovirus infection
October 16, 2018 - Study pinpoints new marker that can predict Crohn’s disease subtype
October 16, 2018 - Simple procedure could be efficacious intervention for failed back surgery
October 16, 2018 - New research identifies modifiable dementia risk factor in elderly people
October 16, 2018 - Zebrafish study uncovers molecular ‘brake’ that helps control eye lens development
October 16, 2018 - Overlapping copy number variations underlie autism and schizophrenia in Japanese patients
October 16, 2018 - Early menopause and diabetes may reduce life expectancy
October 16, 2018 - Majority of Americans’ ancestry can be traced through existing DNA databases
October 16, 2018 - Patients coerced into mental health care less likely to perceive treatment as effective
October 16, 2018 - Healthy elders can consume walnuts without having negative impact on weight gain, finds study
October 16, 2018 - Interactive robot helps older people exercise and detects underlying health problems
October 16, 2018 - What you need to know about autism spectrum disorder
October 16, 2018 - Antidepressants can be used to treat Alzheimer’s disease
October 16, 2018 - Study uncovers important role of PRMT1 in dilated cardiomyopathy
October 16, 2018 - Nutritional quality of breakfast linked to cardiovascular and metabolic risk factors in children
October 16, 2018 - Study uses novel approach to investigate genetic origins of mental illnesses
October 16, 2018 - Scientists develop dual anthrax-plague vaccine
October 16, 2018 - Poor Outcomes for Hispanic Infants With Congenital Heart Dz
October 16, 2018 - Global study finds youngest in class more likely to be diagnosed with ADHD
October 16, 2018 - Researchers sequence two selfish genes in the fungus Neurospora intermedia
October 16, 2018 - Survey results highlight the need for better communication between patients and HCPs about bacterial vaginosis
October 16, 2018 - Researchers develop fibrin-targeting immunotherapy to protect against neurodegeneration
October 16, 2018 - Researchers create open access database on healthy immunity
October 16, 2018 - Rice University chemist wins big award to study small surfaces
October 16, 2018 - Study finds 43% drop in stroke rate
October 16, 2018 - Researchers identify basic relationships of cell cycle and cellular senescence in the placenta
October 16, 2018 - UA professor receives NSF grant to develop antifouling materials for medical implants
October 16, 2018 - Obesity Doubles Odds for Colon Cancer in Younger Women
October 16, 2018 - Adults with ADHD not constrained in creativity
October 16, 2018 - Raising visibility for people and students with chronic illness and disability
October 16, 2018 - Allele awarded NIH grant to develop nanoantibody therapies for treatment of sepsis
October 16, 2018 - Only 59% of young adults undergoing surgery are fluid responsive
FDA approves Teva’s AJOVY injection for preventive treatment of migraine in adults

FDA approves Teva’s AJOVY injection for preventive treatment of migraine in adults

image_pdfDownload PDFimage_print

Teva Pharmaceutical Industries Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved AJOVYTM (fremanezumab-vfrm) injection for the preventive treatment of migraine in adults. AJOVY, a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor, is the first and only anti-CGRP treatment for the prevention of migraine with quarterly (675 mg) and monthly (225 mg) dosing options.

“Migraine is a disabling neurological disease that affects more than 36 million people in the United States,” said Stephen Silberstein, MD, Director, Jefferson Headache Center at Thomas Jefferson University Hospital, and lead investigator of the Phase III clinical trial program for AJOVY. “About 40 percent of people living with migraine may be appropriate candidates for preventive treatment, yet the majority of them are untreated. I am pleased to have another treatment option that may allow my patients to experience fewer monthly migraine days.”

AJOVY was evaluated in two Phase III, placebo-controlled clinical trials that enrolled patients with disabling migraine and was studied as both a stand-alone preventive treatment and in combination with oral preventive treatments. In these trials, patients experienced a reduction in monthly migraine days during a 12-week period. The most common adverse reactions (≥5 percent and greater than placebo) were injection site reactions.

“This is an important day for Teva and complements our long-standing history of helping patients living with diseases of the central nervous system,” said Kåre Schultz, President and CEO of Teva. “The approval of AJOVY helps us to continue to provide access to important medicines and to deliver on our commitment to our key stakeholders – patients, employees and shareholders.”

“With limited availability of preventive treatment options, AJOVY provides physicians with an important new option for their patients,” said Hafrun Fridriksdottir, Executive Vice President, Global R&D at Teva. “This approval furthers our ongoing commitment and experience in neurological conditions like migraine.”

The U.S. Wholesale Acquisition Cost (WAC) of AJOVY is $575 per monthly dose and $1,725 per quarterly dose. AJOVY will be available through retail and specialty pharmacies in approximately two weeks. There is a savings offer for AJOVY. Commercially insured patients may pay as little as $0 on prescriptions for AJOVY until the offer expires. Teva Shared Solutions® is available to provide support services for patients and offices. Visit AJOVY.com to learn more.

“Today’s approval is an important step forward for Teva and the migraine community,” said Brendan O’Grady, Executive Vice President and Head of North America Commercial at Teva. “Our entire organization is proud to bring this new biologic product forward at a responsible price, and we are eager to work with insurers to encourage coverage that provides full access and availability in this much needed category.”

Source:

https://www.tevapharm.com/news/teva_announces_u_s_approval_of_ajovytm_fremanezumab_vfrm_injection_the_first_and_only_anti_cgrp_treatment_with_both_quarterly_and_monthly_dosing_for_the_preventive_treatment_of_migraine_in_adults_09_18.aspx

Tagged with:

About author

Related Articles