HERTFORDSHIRE, England
and PITTSBURGH and BANGALORE,
India, July 6, 2020
/PRNewswire/ -- Mylan N.V. (NASDAQ: MYL) today announced that
the Drug Controller General of India (DCGI) has
approved its remdesivir 100 mg/vial for restricted emergency
use in India as part of the DCGI's
accelerated approval process to address urgent, unmet needs amid
the evolving coronavirus 2019 (COVID-19) pandemic. The drug is
approved for the treatment of suspected or laboratory confirmed
incidences of COVID-19 in adults and children hospitalized with
severe presentations of the disease. The drug will be launched
under the brand name DESREM™ in India, and will be available to patients in
July at a price of INR 4,800, which is more than 80% less than the
price at which the branded version of this product will be
available to governments in the developed world.
Mylan will manufacture remdesivir in India at its world-class injectables
facilities, which also make product for the U.S. and have been
inspected by the U.S. Food and Drug Administration (FDA) for
compliance with good manufacturing practices. The company continues
to work extensively toward expanding emergency use access for
patients in the 127 low- and middle-income countries where it is
licensed by Gilead Sciences to do so, subject to reviews by
national regulatory bodies and the Prequalification Program of the
World Health Organization (WHO). The approval by DCGI in
India represents the first for
Mylan in these 127 markets.
Mylan President Rajiv
Malik said: "Mylan and Gilead Sciences have
partnered for many years to make high quality medicines available
to people who need them and have made significant progress to
reduce the incidence of infectious diseases, including
HIV/AIDS, around the world. We commend Gilead for their continued
leadership on this front, and also applaud and are proud to
continue partnering with the DCGI for its ongoing efforts to
accelerate access to critical medicine for patients with COVID-19
in India."
Malik continued: "Our approval is a significant milestone for
Mylan, for the global public health community and, most
importantly, for patients who are battling this pandemic.
Developing DESREM™ and bringing it to patients in India with such unprecedented speed is a
testament to the strength of our global operations and scientific
capabilities and our commitment to serving patients who continue to
rely on us during this time. We are proud to continue our work
in support of public health in partnership with governments and
other stakeholders as we work together in the fight against
COVID-19."
Rakesh Bamzai, President,
India and Emerging Markets,
said: "The growing global threat of COVID-19 requires a commitment
to action by everyone involved in public health. Mylan is cognizant
of its responsibility in fighting this pandemic and will leverage
its global resources and capabilities including R&D,
regulatory, manufacturing and supply chain, while engaging with key
stakeholders across the licensed territories to serve the patients
in need and further its mission of creating better health for a
better world."
Mylan previously announced a global collaboration agreement with
Gilead Sciences for the commercialization of remdesivir in 127
low- and middle-income countries, including India. Mylan has a long-standing history of
partnering with Gilead to tackle key public health issues in
India and around the world,
beginning with expanding access to high quality, affordable
HIV/AIDS antiretrovirals and now extending its partnership to
include COVID-19 treatments. Remdesivir is the tenth medicine
licensed to Mylan by Gilead, who signed their first agreement in
2006 for the HIV medicine, tenofovir disoproxil fumarate.
As a leading global pharmaceutical company, Mylan is committed
to continue doing its part in support of public health needs. As
the situation around COVID-19 continues to evolve, Mylan's
priorities remain protecting the health and safety of its
workforce, continuing to produce critically needed medicines,
deploying our resources and expertise in the fight against COVID-19
through potential prevention and treatment efforts, and supporting
the communities in which we operate.
About Remdesivir
Remdesivir is an investigational new
drug developed by Gilead Sciences. Interim results of two large
Phase III clinical trials have demonstrated favourable outcomes
with Remdesivir. Based on the results, USFDA granted emergency use
authorization (EUA) of Remdesivir to treat hospitalized patients
with severe COVID-19 in the U.S. In addition, it is recommended for
compassionate use in Europe and recently received
regulatory approval in Japan, Taiwan and Singapore.
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
portfolio of more than 7,500 marketed products around the world,
including antiretroviral therapies on which approximately 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.
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SOURCE Mylan N.V.