Mylan Leads Pipeline NewsBy
A roundup of the latest market developments from the pipelines of the pharmaceutical majors, featuring news from Mylan.
Editor’s Note: This article was updated on a continuous basis for news announced from Wednesday, February 14, 2017 to Tuesday, February 20, 2017.
FDA Grants Mylan Tentative Approval for Combination HIV Drug
The US Food and Drug Administration (FDA) has granted tentative approval for Mylan’s new drug application for dolutegravir, emtricitabine, and tenofovir alafenamide tablets, for treating human immunodeficiency virus (HIV). This was approved under the US President’s Emergency Plan for AIDS Relief, a five-year bilateral commitment by the US Government to support HIV/AIDS treatment programs in developing countries.
Mylan says its antiretroviral (ARV) will be immediately available in developing countries as a first-line regimen for people being treated for HIV/AIDS.
Mylan’s ARV is a once-daily, fixed-dose combination of the individual components that make up ViiV Healthcare’s Tivicay (dolutegravir) and Gilead Sciences’ Descovy (emtricitabine and tenofovir alafenamide). Mylan manufactures these products under licenses from the Medicines Patent Pool, a United Nations-backed public health organization, and Gilead Sciences, respectively. This is the first tentative approval of tenofovir alafenamide and comes two years after the FDA approval of Gilead Sciences’ Descovy.