Breaking News
April 24, 2018 - Study shows people might develop dementia later and live with it for a shorter period of time
April 24, 2018 - EMBL scientists develop new illumination method to manage neuropathic pain
April 24, 2018 - New compound could offer pain-relieving properties without risk of addiction
April 24, 2018 - New drug treatment could be promising therapeutic approach for millions with asthma
April 24, 2018 - Study provides guidance on using cannabis for treatment of stress, anxiety, and depression
April 24, 2018 - By Royal approval: Queen’s Award success for Elucigene
April 24, 2018 - The role of ‘extra’ DNA in cancer evolution and therapy resistance
April 24, 2018 - Researchers identify tools that caregivers could use to detect delirium in older adults
April 24, 2018 - What to Look Out For
April 24, 2018 - Drugs prescribed for newborns vary widely between NICUs, study finds
April 24, 2018 - FM4200 pressure-resistant mass flow meter from Sensirion
April 24, 2018 - Study links past experiences with bias and avoidance of doctors in women with higher BMI
April 24, 2018 - Role of extrachromosomal pieces of DNA in cancer development and treatment resistance
April 24, 2018 - Rehabilitation technique for stroke appears beneficial for multiple sclerosis patients
April 24, 2018 - Catalyst Pharmaceuticals Announces Submission of New Drug Application for Firdapse for Treatment of Lambert-Eaton Myasthenic Syndrome
April 24, 2018 - Suicide and homicide rates show large racial disparities across US states
April 24, 2018 - NuProbe to commercialize Wyss Institute’s new technology to facilitate precision medicine
April 24, 2018 - Special series explores pasteurized donor human milk use for hospitalized infants
April 24, 2018 - Slight changes in patient’s position during radiotherapy may impact survival chances
April 24, 2018 - FDA Approves Tagrisso (osimertinib) as First-Line Treatment for EGFR-Mutated Non-Small Cell Lung Cancer
April 24, 2018 - After knee replacement, play on
April 24, 2018 - Contact precautions do not limit spread of drug-resistant bacteria in ICUs
April 24, 2018 - Researchers discover genetic catalysts that accelerate evolution of antibiotic resistance in bacteria
April 24, 2018 - WPI researcher launches mobile app for assessing perinatal depression in women
April 24, 2018 - Researchers identify superior blood-based biomarker for assessing sports-related concussions
April 24, 2018 - Gene Therapy Found to Be Promising for β-Thalassemia
April 24, 2018 - Bariatric surgery can lead to changes in relationship status
April 24, 2018 - GPs must embrace digital technologies to make healthcare access easier for patients
April 24, 2018 - Novel stem cell therapy may transform current paradigms for treating heart failure patients
April 24, 2018 - Maternal depression during and after pregnancy linked to poorer child neurodevelopment
April 24, 2018 - Vitamin D and magnesium supplements provide right nutritional support to athletes
April 24, 2018 - Could a Tattoo Someday Spot Your Cancer?
April 24, 2018 - Throat reflexes differ in people with tetraplegia and sleep apnea
April 24, 2018 - Study shows no increased risk of breast cancer recurrence after DIEP flap reconstruction
April 24, 2018 - Nearly three-quarters of commonly used medical scopes tainted by bacteria
April 24, 2018 - Home-based treatment program offers robust and sustained relief for IBS patients
April 24, 2018 - New IntelliCyt Cy-Clone PLUS streamlines clone ranking and selection for cell line development
April 24, 2018 - Scientists examine how specific eating patterns could help fight cancer and obesity
April 24, 2018 - Study sheds new light on how bilinguals process language
April 24, 2018 - Probiotics can improve liver health, shows study
April 24, 2018 - Study may explain how chemoresistance evolves over time in some triple-negative breast cancers
April 24, 2018 - Role of midbrain in encoding identity errors
April 23, 2018 - Salamander study provides clues for treating spinal cord injuries
April 23, 2018 - Relaxation after work could give better night’s sleep
April 23, 2018 - Loneliness on its way to becoming Britain’s most lethal condition
April 23, 2018 - Low-cost blood test for multiple myeloma can deliver same diagnostic information as bone biopsy
April 23, 2018 - Metabolic differences may contribute to postpartum weight retention in black moms
April 23, 2018 - Time-Related Deployment Factors Predict Suicide Attempt Risk
April 23, 2018 - Are newborns ugly? Research says newborns rated ‘less cute’ than older babies
April 23, 2018 - Prenatal marijuana use linked to increased chance of low birth weights
April 23, 2018 - Researchers identify target gene in P. aeruginosa infection
April 23, 2018 - New studies related to causes of liver degradation and possible treatments
April 23, 2018 - Studies offer leads for new approaches to treat neurological problems
April 23, 2018 - Promising cell study may offer new opportunities for treating Parkinson’s disease
April 23, 2018 - Gene Therapy May Be Cure for Some With Rare Blood Disorder
April 23, 2018 - Obesity impacts liver health in kids as young as eight years old
April 23, 2018 - Frequent cannabis use by young people linked to small reductions in cognitive function
April 23, 2018 - Innovative research could lead to new ways to treat, prevent cancer
April 23, 2018 - Study uncovers possible source of gender differences in migraines
April 23, 2018 - Study proves usefulness of EDX testing in diagnosis, management of neuromuscular disorders
April 23, 2018 - Hacking ‘drug trafficking’ system could increase effectiveness of diabetes treatment
April 23, 2018 - Clinical trial to examine stem cell therapy for treatment, prevention of complications after traumatic injury
April 23, 2018 - Targeted radiotherapy found to be a good option for women with early breast cancer
April 23, 2018 - Eating fish could prevent Parkinson’s disease
April 23, 2018 - Philips showcases dedicated radiation oncology solutions at ESTRO 2018
April 23, 2018 - Key factor in development of Parkinson’s disease identified
April 23, 2018 - Higher consumption of fish linked to better neurological health
April 23, 2018 - Genevac announces HT Series 3 evaporators with Inert Gas Purge option
April 23, 2018 - Researchers clarify immune response for patients with breast cancer brain metastases
April 23, 2018 - Polypharmacy More Likely for Cancer Survivors
April 23, 2018 - Obesity is shifting cancer to young adults
April 23, 2018 - Scientists illustrate role of novel chromosomal mutations in fosfomycin resistance
April 23, 2018 - Newly developed drug compound may help treat Charcot-Marie-Tooth disease
April 23, 2018 - Marriage Means ‘I Do’ for Skin Cancer Detection
April 23, 2018 - Freezing hunger-signaling nerve may help ignite weight loss
April 23, 2018 - Wear exoskeletons with caution for heavy lifting, researchers say
April 23, 2018 - Research offers new hope for healing wounds in patients with diabetes
April 23, 2018 - Shorter courses of radiotherapy found to be safe, effective for prostate cancer patients
April 23, 2018 - Scientists use CRISPR tool to make multiple edits to DNA samples ‘in vitro’
April 23, 2018 - Knee reconstructions are on the rise among the youth in Australia
Mylan Introduces Symfi (efavirenz, lamivudine and tenofovir disoproxil fumarate) Triple Combo Once-Daily HIV Treatment in the U.S.

Mylan Introduces Symfi (efavirenz, lamivudine and tenofovir disoproxil fumarate) Triple Combo Once-Daily HIV Treatment in the U.S.

image_pdfDownload PDFimage_print

Mylan Introduces Symfi (efavirenz, lamivudine and tenofovir disoproxil fumarate) Triple Combo Once-Daily HIV Treatment in the U.S.

HERTFORDSHIRE, England and PITTSBURGH, March 28, 2018 /PRNewswire/ — Global pharmaceutical company Mylan N.V. (NASDAQ: MYL) today announced that it will introduce in the U.S. a third cost-saving HIV combination. The U.S. Food and Drug Administration (FDA) approved Symfi (efavirenz, lamivudine and tenofovir disoproxil fumarate) 600 mg/300 mg/300 mg tablets, a once-daily, single-tablet regimen (STR), indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 40 kg.

“As the largest supplier of antiretrovirals by volume in the world, Mylan has a longstanding commitment to expanding affordable access to treatments for people living with HIV,” said Mylan CEO Heather Bresch. “As we continue to grow our U.S. portfolio of ARV products, now including Symfi Lo™, Symfi™, and Cimduo™, we are providing access to patients and empowering them to choose the lower-cost ARV treatment option that is right for them.”

The introduction of Symfi™ comes after the FDA’s recent approval of two Mylan ARVs: Cimduo™ (lamivudine and tenofovir disoproxil fumarate) 300 mg/300 mg tablets, a once-daily combination of two nucleo(t)side reverse transcriptase inhibitors, which is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing at least 35 kg.; and Symfi Lo™ (efavirenz, lamivudine and tenofovir disoproxil fumarate) 400 mg/300 mg/300 mg tablets, also approved for patients with HIV-1 in adults and pediatric patients weighing at least 35 kg.

Following FDA approval, Mylan launched Symfi Lo™ earlier in March. It expects Cimduo™ and Symfi™ to launch in the second quarter of 2018.

Symfi™ and Symfi Lo™ feature the same triple combination of molecules; however, Symfi Lo™ features a reduced dose of efavirenz while Symfi™ uses a dosing similar to other efavirenz products already on the market. The combination represented by Symfi™ (efavirenz, lamivudine and tenofovir disoproxil fumarate) 600 mg/300 mg/300 mg tablets is the most widely-taken ARV regimen outside of the U.S., with more than 7 million users worldwide in 20161.

In 2017, HIV was the category with highest pharmacy spend for Medicaid, the third highest for health exchange plans and the fifth highest for commercial plans.2 According to IQVIA, total spending on HIV drugs has more than tripled since 2007, outpacing the approximate 60% growth in overall drug spending.

To help reduce the high cost of HIV treatment in the U.S, the list price of these Mylan ARVs will be discounted significantly from the wholesale acquisition cost of similar medicines on the market.

“Mylan has been on the forefront of bringing innovative delivery and dosage forms of ARVs to millions of patients in the developing world,” said Mylan President Rajiv Malik. “We’ve already extended our reach to people in the U.S. living with HIV with the introduction of Symfi Lo™ and Cimduo™. Adding Symfi™ to our portfolio further strengthens our commitment to investing in developing and manufacturing these important products.”

Lactic acidosis and hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues including lamivudine and tenofovir disoproxil fumarate. Severe acute exacerbations of hepatitis B have been reported in patients who are co-infected with hepatitis B virus and HIV who have discontinued lamivudine and tenofovir disoproxil fumarate.

Mylan’s Commitment to the HIV/AIDS Patient Community

Mylan is the world’s largest supplier by volume of HIV/AIDS therapies. More than 40% of the 20 million patients on treatment worldwide depend on a Mylan product every day. For more than a decade, Mylan has been a leader in providing access to quality, dependable and affordable ARVs in 100 countries around the world. This includes introducing in 2009 the first generic one-tablet-once-a-day combination for developing countries – only three years after the originator product launched in the U.S. Since that time, Mylan has been the first to market with nearly half of the new products tentatively approved by the FDA under PEPFAR. Mylan was also the first generic drug maker to develop for low- and middle-income countries a heat-stable version of a drug critical for second-line regimens, and is the leading worldwide supplier of pediatric ARVs, including taste-masked and dispersible formulations. Mylan has long been a supporter of the patient community through the sponsorship of free community HIV/AIDS testing and clinical research. Learn more about Mylan’s work with infectious disease here. Watch this video to learn more about Mylan’s commitment to people living with HIV/AIDS.

This press release includes statements that constitute “forward-looking statements”, including with regard to: all ARV regimens being offered at a significant discount to the price of competing products to bring cost savings to the $20 billion U.S. ARV market; that Mylan expects Cimduo™ and Symfi™ to launch in the second quarter of 2018; and that to help reduce the high cost of HIV treatment in the U.S, the list price of these Mylan ARVs will be discounted significantly from the wholesale acquisition cost of similar medicines on the market. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: success of clinical trials and our or our partners’ ability to execute on new product opportunities; any regulatory, legal or other impediments to our or our partners’ ability to bring products to market; other risks inherent in product development; the scope, timing, and outcome of any ongoing legal proceedings, including government investigations, and the impact of any such proceedings on our or our partners’ businesses; actions and decisions of healthcare and pharmaceutical regulators, and changes in healthcare and pharmaceutical laws and regulations, in the United States and abroad; the impact of competition; strategies by competitors or other third parties to delay or prevent product introductions; the effect of any changes in our or our partners’ customer and supplier relationships and customer purchasing patterns; any other changes in third-party relationships; changes in the economic and financial conditions of the businesses of Mylan or its partners; uncertainties and matters beyond the control of management; and the other risks detailed in Mylan’s filings with the Securities and Exchange Commission. Mylan undertakes no obligation to update these statements for revisions or changes after the date of this release.

About Mylan

Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what’s right, not what’s easy; and impact the future through passionate global leadership. We offer a growing portfolio of more than 7,500 marketed products around the world, including antiretroviral therapies on which more than 40% of people being treated for HIV/AIDS globally depend. We market our products in more than 165 countries and territories. We are one of the world’s largest producers of active pharmaceutical ingredients. Every member of our approximately 35,000-strong workforce is dedicated to creating better health for a better world, one person at a time. Learn more at Mylan.com. We routinely post information that may be important to investors on our website at investor.mylan.com.


1 https://clintonhealthaccess.org/content/uploads/2017/09/2017-ARV-Market-Report_Final-2.pdf
2 http://lab.express-scripts.com/lab/drug-trend-report/2017-dtr

SOURCE Mylan N.V.

Tagged with:

About author

Related Articles