Netherlands-based drugmaker Mylan (Nasdaq: MYL) has received marketing authorization from the Drug Controller General of India for its antiretroviral (ARV) drug Avonza (TLE400).
This treatment is a fixed-dose combination comprised of efavirenz, lamivudine and tenofovir disoproxil fumarate tablets, 400mg/300mg/300mg, recommended by the World Health Organization as an alternative first-line regimen for people being treated for HIV/AIDS.
Mylan president Rajiv Malik said, “Developing Avonza and bringing it to patients with HIV in India is a continuation of our strong and sustained commitment to expanding access to affordable, high quality ARVs.
“Avonza will be available to patients at a cost that is lower than that of other current first-line ARVs. What’s more, Mylan is the first to offer this combination in India, making it another example of the innovative spirit that runs throughout our company to adapt our medicines, accelerate access and improve treatment outcomes.”
Mylan supplies life-saving ARVs to nearly 50% of patients being treated for HIV/AIDS in more than 100 developing countries. India has the third-largest HIV epidemic in the world, and in April of this year, the country’s Health Ministry launched the test and treat policy for HIV, meaning anyone testing positive will get antiretroviral therapy irrespective of CD4 count or clinical stage.