Mylan's Matrix gets tentative FDA approval under PEPFAR for generic Atripla HIV Treatment

US generic drug major Mylan says that Matrix Laboratories, an Indian company in which it owns a controlling stake, has received tentative approval from the US Food and Drug Administration under the President's Emergency Plan for AIDS Relief (PEPFAR) for its Abbreviated New Drug Application for a fixed-dose combination of efavirenz, emtricitabine, tenofovir disoproxil fumarate tablets, 600mg/200mg/300 mg. This is the first and only generic version of this product and will be eligible for purchase outside the U.S. in many developing countries.

Mylan president Heather Bresch said: "This critical approval only further strengthens Mylan and Matrix's efforts to expand access to life-saving, affordable AIDS treatments for people living with HIV/AIDS in developing countries. Matrix's generic fixed-dose combination will dramatically improve access to this more patient-friendly medication while reducing the cost of treatment. Our commitment to growing Matrix's ARV (antiretroviral) franchise goes hand-in-hand with our desire to raise the standard of care in developing countries to the levels available in countries like the USA."

Matrix's product is a generic version of Gilead Sciences' Atripla, which is indicated for the treatment of HIV-1 infection in adults. It combines three anti-AIDS medicines into a single daily dose for either first- or second-line treatment and is one of the best-selling AIDS products in developed countries, with approximately $1.6 billion in US sales alone for the 12 months ending June 30, according to IMS Health. Until now, a generic version of this product has not been available in any market. Cocktails combining numerous drugs into a once daily dose can dramatically reduce pill burden, an improvement which has been shown to enhance patient compliance with complex treatment regimens, says Mylan.