ViiV Healthcare and CHAI collaboration delivers second milestone with first filing with the FDA of generic dolutegravir by Aurobindo Pharma for the treatment of HIV
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Tuesday, June 2, 2015
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LONDON, United-Kingdom, May 26, 2015/ -- ViiV Healthcare (http://www.viivhealthcare.com ), Aurobindo Pharma (http://www.aurobindo.com), and the Clinton Health Access Initiative, Inc. (CHAI) (http://www. clintonhealthaccess.org)
announced today that Aurobindo Pharma has submitted an Abbreviated New
Drug Application (ANDA) for dolutegravir 50mg, for Tentative Approval,
to the Food and Drug Administration (FDA), for the treatment of HIV.
This is the first ANDA for a generic version of dolutegravir, less than
two years after FDA approval of Tivicay® (dolutegravir) for sale in the
United States.
Upon
receiving Tentative Approval from the FDA, Aurobindo Pharma will be
able to supply dolutegravir 50mg via the President’s Emergency Plan for
AIDS Relief (PEPFAR) programme, following completion of required local
regulatory approval process, in the licensed countries outside of the
United States, as per the agreement signed between Aurobindo Pharma and
ViiV Healthcare in 2014.
This
submission comes less than five years after ViiV Healthcare and CHAI
signed an agreement to collaborate with the goal of bringing innovative
formulations of medicines for the treatment and prevention of HIV/AIDS
to people living with HIV in developing countries, on an affordable yet
sustainable basis.
CHAI
and ViiV Healthcare worked together to identify a generic partner after
conducting feasibility research. Following this initial joint work,
ViiV Healthcare submitted necessary documentation to the FDA providing a
selective waiver letter for the five-year period of New Chemical Entity
(NCE) exclusivity that would have otherwise prevented FDA review and
Tentative Approval of Aurobindo Pharma’s ANDA at this time.
Dr.
Dominique Limet, CEO, ViiV Healthcare, said: “This first ANDA for a
generic dolutegravir confirms that our strong commitment to thinking and
acting differently to pursue new ways to expand access to our
medicines, for people living with HIV in countries where the need is
most pressing, is working.”
David
Ripin, PhD, Executive Vice President, and Chief Scientific Officer,
CHAI, said: “UNAIDS has set global public health goals calling for 90
percent of those who are HIV-positive to know their status, 90 percent
of those identified to be linked to treatment programs, and 90 percent
of those in treatment to achieve undetectable viral load. To tackle
these complex challenges, targeted efforts to facilitate access to HIV
treatment medicines, such as dolutegravir, are needed.”
Mr.
N. Govindarajan, Managing Director, Aurobindo Pharma, said: “We are
pleased to be part of this innovative partnership designed to accelerate
access to medicines for treating HIV. Aurobindo Pharma is committed to
HIV care and aims to achieve the goals of wider access to HIV treatment,
care, and support; seeking to address the spread of HIV through
development of this newer class of drugs and fixed-dose combinations for
low- and middle-income countries. “
The
filing by Aurobindo Pharma is the second result of the agreement
between CHAI and ViiV Healthcare and comes less than six months after
another generic manufacturer announced that it had received Tentative
Approval from the FDA for paediatric formulations of another ViiV
Healthcare antiretroviral (also under PEPFAR for sale in licensed
countries outside of the United States), through innovative
collaboration with ViiV Healthcare and CHAI.
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