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Mylan heads lower as it receives “tentative approval” for HIV/AIDS drug

The treatment combines three first-line therapies – Dolutegravir, Lamivudine and Tenofovir Disoproxil Fumarate – into one smaller tablet that patients take three times a day

african man having blood sample taken at doctor's
There are currently around 37mln people living with HIV/AIDS around the world

Shares in Mylan Inc. (NASDAQ:MYL) dropped in pre-market trade on Monday after the pharma giant confirmed it has received “tentative approval” for its TLD HIV/AIDS antiretroviral (ARV) drug.

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.

Quick facts: Mylan Inc.

Price: 19.665 USD

NASDAQ:MYL
Market: NASDAQ
Market Cap: $10.16 billion
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