The treatment combines three first-line therapies – Dolutegravir, Lamivudine and Tenofovir Disoproxil Fumarate – into one smaller tablet that patients take three times a day.
It’s the first fixed-dose combination of its kind to be offered to patients being treated for HIV/AIDS, Mylan said.
The US Food and Drug Administration gave its ‘tentative approval’ under the US President’s Emergency Plan for AIDS Relief – a governmental initiative designed to address the global HIV/AIDS epidemic, but with a particular focus on Africa.
“Our innovative TLD is a new medicine that will be available specifically to patients in the developing world being treated for HIV/AIDS,” said chairman Rajiv Malik.
“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.”
Shares were down 4.5% in pre-market to US$31.35.