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Mylan to launch two new HIV combination treatments in US

Published 05 March 2018

Mylan said that it will launch two new HIV treatments, Symfi Lo and Cimduo, which have been approved in February this year by the US Food and Drug Administration (FDA).

Mylan anticipates introducing Symfi Lo in the coming weeks and Cimduo in the second quarter of this year. These upcoming launches will extend Mylan's global antiretroviral (ARV) platform and help address the high cost of HIV treatment in the U.S.

Total spending for HIV medications in the U.S. exceeds $20 billion annually, and HIV is a top cost driver for many healthcare payers, such as Medicaid.

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.

Mylan CEO Heather Bresch said: "As the world's largest supplier of antiretrovirals by volume, Mylan is deeply committed to expanding access to treatment for people living with HIV.

"For a decade, we have helped transform the level of access to high-quality, affordable HIV medications in developing countries. We are excited to bring that same passion to the U.S. with the upcoming launches of Symfi Lo and Cimduo and help deliver significant savings to the healthcare system."

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.1 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, 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.

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 World Health Organization in 2016 as an alternative first-line therapy for adults living with HIV infection.

In addition, Mylan has sold the product overseas since March 2017, upon receipt of Tentative Approval by FDA under the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) program.  Worldwide, Mylan supplied the regimen to more than one million patients in 2017.

According to the Kirby Institute's ENCORE1 study, 400 mg efavirenz was found to be non-inferior to 600 mg efavirenz when combined with tenofovir and emtricitabine in adults with HIV-1 infection who had never undergone treatment.2 Symfi Lo is the second efavirenz-based STR approved by the FDA and the first to use the lower dose of efavirenz.

Source: Company Press Release