Mylan to Introduce Two New Cost-Saving HIV Combination Treatments in the U.S.
Symfi Lo (efavirenz, lamivudine and tenofovir disoproxil fumarate) 400 mg/300 mg/300 mg tablets is a once-daily, single-tablet regimen (STR) and is 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 35 kg. Cimduo™ (lamivudine and tenofovir disoproxil fumarate) 300 mg/300 mg tablets is a once-daily combination of two nucleo(t)side reverse transcriptase inhibitors and 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.
"As the world's largest supplier of antiretrovirals by volume, Mylan is deeply committed to expanding access to treatment for people living with HIV," said Mylan CEO
In 2017, HIV was the category with highest pharmacy spend for
To help reduce the high cost of HIV treatment in the U.S, Symfi Lo's list price will be discounted significantly from the wholesale acquisition cost (WAC) of any other STR on the U.S. market today. Cimduo's list price will likewise be at a significant discount to any other tenofovir-based double combination product on the U.S. market today.
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.
Evolving the Science with a New, Low-dose Option
Symfi Lo is an STR formulated with a 400 mg dose of efavirenz, which is one-third less than the dose originally approved in 1998. The fixed-dose combination was recommended by the
"Symfi Lo and Cimduo bring to the U.S. the innovations Mylan has pioneered in the delivery and dosage forms of ARVs used by millions of patients in high-burden countries around the world. We are proud of our continued investments in R&D and manufacturing for ARVs, and we are excited to extend the value of these to Americans living with HIV," said Mylan President
According to the
Mylan's Commitment to the
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
This press release includes statements that constitute "forward-looking statements", including with regard to: Mylan announcing that in the coming weeks it will launch two new HIV treatments, Symfi LoTM and CimduoTM, which were approved in February by the
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.
2 Efficacy of 400 mg efavirenz versus standard 600 mg dose in HIV-infected, antiretroviral-naive adults (ENCORE1): a randomised, double-blind, placebo-controlled, non-inferiority trial; http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(13)62187-X/abstract
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Lauren Kashtan (Media), 724.514.1968; Melissa Trombetta (Investors), 724.514.1813