Mylan announces plans for low-cost AIDS treatment
CANONSBURG – Mylan N.V. said Tuesday it expects to be the first to launch, upon regulatory approval and for developing country markets funded by international donors, a low-cost AIDS treatment for $99 per patient, per year.
The company’s TLE400 (Tenofovir Disoproxyl Fumarate 300 mg + Lamivudine 300 mg + Efavirenz 400 mg) is an antiretroviral drug that Mylan partnered with the Clinton Health Access Initiative to develop.
Announced on World AIDS Day, Mylan said in a news release the significantly reduced price could generate savings of tens of millions of dollars for national AIDS programs that aim to double the 15 million people on ARV treatment in developing countries. Mylan said it expects to file a new drug application for TLE400 with the U.S. Food and Drug Administration in the first quarter of 2016.
The World Health Organization is releasing new ARV guidelines that incorporate, for the first time, TLE400 as an alternative first-line regimen for patients intolerant to the most commonly prescribed combinations today, which use Efavirenz 600 mg.
Mylan said although there is insufficient data for WHO to recommend TLE400 in persons with tuberculosis co-infection or women who are pregnant, related studies are planned or underway. These studies are being funded by Mylan, in partnership with CHAI, to explore the maximum potential benefits of the product to patients living with HIV.
FDA tentative approval or prequalification by the WHO is a prerequisite for the purchase of ARVs using funds from international donors such as the Global Fund to Fight AIDS, Tuberculosis and Malaria and the U.S. President’s Emergency Plan for AIDS Relief.
Mylan said it expects to be the first company to file TLE400 with FDA and/or WHO and anticipates being the first to market the product for donor-funded procurement in developing countries.
“This World AIDS Day is an opportunity to reflect on the tremendous progress that has been made in the fight against HIV/AIDS, in particular, the 15 million people in developing countries who now have access to ARV treatment, Mylan CEO Heather Bresch said. “However, today also is a time to recognize that there is much more work to be done to increase access to treatment and to end this epidemic.”
Mylan currently supplies life-saving ARV medicines to nearly 50 percent of the men, women and children living with the disease and accessing treatment in more than 100 developing countries.