HERTFORDSHIRE, England
and PITTSBURGH, Feb. 20, 2018
/PRNewswire/ -- Global pharmaceutical company Mylan N.V. (NASDAQ:
MYL) today announced receipt of tentative approval from the U.S.
Food and Drug Administration (FDA) under the U.S. President's
Emergency Plan for AIDS Relief (PEPFAR) for its New Drug
Application for Dolutegravir, Emtricitabine, and Tenofovir
Alafenamide Tablets, 50 mg/200 mg/25 mg. The antiretroviral (ARV)
will be immediately available in developing countries as a
first-line regimen for people being treated for HIV/AIDS.
Mylan is the world's largest producer of HIV/AIDS drugs, and
more than 40% of people being treated worldwide for HIV/AIDS depend
on a Mylan antiretroviral product.
"The FDA's tentative approval of Mylan's Dolutegravir,
Emtricitabine, and Tenofovir Alafenamide Tablets sets a new
standard for affordable access for patients in countries hardest
hit by HIV, as it's the first time a product combines dolutegravir
and tenofovir alafenamide," said Mylan CEO Heather Bresch. "With limited funding, the world
needs cost competitive and clinically effective products like this
one, and Mylan is proud to work with partners to make it available
and help reach the more than 15 million people living with HIV
worldwide who still need access to treatment."
Mylan's ARV is a once-daily, fixed-dose combination of
Dolutegravir, Emtricitabine and Tenofovir Alafenamide, the
individual components that make up ViiV Healthcare's
Tivicay® and Gilead's Descovy®. Mylan
manufactures these products under licenses from the Medicines
Patent Pool and Gilead Sciences, respectively. This is the first
tentative approval of Tenofovir Alafenamide and comes just two
years after the FDA approval of Descovy®. The combination of
these agents is currently included as a "Recommended Initial
Regimen for Most People with HIV" in the HIV guidelines of the U.S.
Department of Health and Human Services.
"In the past decade, Mylan has committed itself again and again
to bringing new therapeutic options to people living with HIV as
quickly as possible and to as many people as possible," said Mylan
President Rajiv Malik. "We are proud
that nearly half of the FDA's tentative approvals under PEPFAR are
Mylan products. In the last year alone, we have been the first
company to receive approval for three new fixed-dose combination
products that use a lower dose of Efavirenz, Dolutegravir, and now
Dolutegravir in combination with Tenofovir Alafenamide."
The tablet will be the smallest sized single-tablet regimen
available for patients in the developing world. It will be offered
in a 90-day package as well as a 30-day one, potentially allowing
patients fewer trips to the clinics for a refill.
Mylan's Commitment to the Treatment of HIV/AIDS
For
more than a decade, Mylan has been a leader in providing access to
quality, dependable and affordable ARVs in more than 100 countries
around the world. This includes introducing in 2009 the first
generic one-tablet-once-a-day combination for developing countries
– only three years after the originator product launched in the
U.S. Since that time, Mylan has been the first to market with
nearly half of the new products approved under the FDA's PEPFAR
program. Mylan was also the first generic drug maker to develop a
heat-stable version of a drug critical for second-line regimens,
and is the leading supplier of pediatric ARVs, including
taste-masked and dispersible formulations. Mylan has also long been
a supporter of the patient community through the sponsorship of
free community HIV/AIDS testing and clinical research. Learn more
about Mylan's work with infectious disease here. Watch this
video to learn more about Mylan's commitment to people living
with HIV/AIDS.
About Mylan
Mylan is a global pharmaceutical company
committed to setting new standards in healthcare. Working together
around the world to provide 7 billion people access to high quality
medicine, we innovate to satisfy unmet needs; make reliability and
service excellence a habit; do what's right, not what's easy; and
impact the future through passionate global leadership. We offer a
growing portfolio of more than 7,500 marketed products around the
world, including antiretroviral therapies on which more than 40% of
people being treated for HIV/AIDS globally depend. We market our
products in more than 165 countries and territories. We are one of
the world's largest producers of active pharmaceutical ingredients.
Every member of our approximately 35,000-strong workforce is
dedicated to creating better health for a better world, one person
at a time. Learn more at Mylan.com. We routinely post information
that may be important to investors on our website at
investor.mylan.com.
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SOURCE Mylan N.V.