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Aurobindo Pharma seeks US FDA tentative approval for generic dolutegravir to treat HIV

Our Bureau, Mumbai
Wednesday, May 27, 2015, 15:30 Hrs  [IST]

ViiV Healthcare, Aurobindo Pharma, and the Clinton Health Access Initiative, Inc. (CHAI) announced that Aurobindo Pharma, a Rs. 8,000 crore Indian pharma major, 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 per cent of those who are HIV-positive to know their status, 90 per cent of those identified to be linked to treatment programs, and 90 per cent 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.”

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.

The Clinton Health Access Initiative, Inc. (CHAI)  was founded in 2002 with a transformational goal: help save the lives of millions of people living with HIV/AIDS in the developing world by dramatically scaling up antiretroviral treatment.

ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline (GSK) and Pfizer dedicated to delivering advances in treatment and care for people living with HIV. Shionogi joined as a shareholder in October 2012. The company’s aim is to take a deeper and broader interest in HIV/AIDS than any company has done before and take a new approach to deliver effective and new HIV medicines, as well as support communities affected by HIV.

Aurobindo Pharma Ltd. is a vertically integrated pharmaceutical company that delivers innovative solutions. Aurobindo Pharma leverages India's globally competitive cost base and talented team of scientists to discover, develop, and commercialize a range of affordable medicines for markets across the globe.

PEPFAR is the US government initiative to help save the lives of those suffering from HIV/AIDS around the world. This historic commitment is the largest by any nation to combat a single disease internationally. In May 2004, in support of the President's Emergency Plan, the FDA announced a new initiative to help ensure that those being served by the President’s Plan would receive safe, effective, and quality manufactured antiretroviral drugs.


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