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Mylan gets tentative approval for “TLD” under PEPFAR

Mylan got Monday receipt of tentative approval from the U.S. Food and Drug Administration under the U.S.President’s Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application for Dolutegravir, Lamivudine and Tenofovir Disoproxil Fumarate Tablets.

TLD, an antiretroviral (ARV) fixed-dose combination, will be available in developing countries as a first-line regimen for people being treated for HIV/AIDS. Mylan’s TLD combines molecules from three originator medicines – ViiV Healthcare’s Tivicay  and Epivir and Gilead Science’s Viread.

Mylan President Rajiv Malik said: “Our innovative TLD is a new medicine that will be available specifically to patients in the developing world being treated for HIV/AIDS. We know the challenges they face accessing high quality, affordable ARVs. That’s why our scientists worked diligently to develop a medicine that combines three of the leading first-line regimens into a new, smaller tablet that patients have to take only once each day.”

In July 2017, the WHO recommended national programs evaluate using DTG as a first-line therapy. The recommendation is based on the medicine’s improved tolerability, higher antiretroviral efficacy, lower rates of treatment discontinuation, a higher genetic barrier to resistance and fewer drug interactions than other ARV drugs. Additionally, both the U.S. Department of Health and Human Servicesand the European AIDS Clinical Society include DTG as a preferred medicine on their HIV/AIDS treatment guidelines.

Globally, Mylan supplies life-saving ARVs to nearly 50% of patients being treated for HIV/AIDS in more than 100 developing countries. The company’s comprehensive ARV portfolio includes 14 APIs and 50 finished dosage forms in first-line, second-line and pediatric formulations.

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