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Aurobindo gets tentative FDA approval for HIV drug

Aurobindo Pharma Ltd. has gained tentative approval from the Food and Drug Administration for dolutegravir 50 mg, an HIV medication.

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HYDERABAD, India — Aurobindo Pharma Ltd. has gained tentative approval from the Food and Drug Administration for dolutegravir 50 mg, an HIV medication.

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Aurobindo said Thursday that the move enables the company to launch the product, a generic equivalent of Tivicay from ViiV Healthcare, in the President’s Emergency Plan For AIDS Relief (PEPFAR) market. Launched in 2004, PEPFAR is a U.S. government initiative to address the global HIV/AIDS epidemic.

“The approval of the generic version of DTG [dolutegravir] shows the commitment towards the larger cause of bringing affordable HIV drugs to millions of people,” stated N. Govindarajan, managing director at Aurobindo. “This is a one-of-its-kind agreement between innovator and generic company, where the generic version of the drug will be launched in around three years from the originator product. Further, we are also developing a fixed-dose combination of DTG.”

Aurobindo that the FDA’s move marks the first approval of a generic version of dolutegravir, an integrase strand transfer inhibitor recommended for use in treatment-naive patients by the Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO).

Dolutegravir  is indicated for the treatment of the HIV-1 infection in combination with other antiretroviral agents. Through a collaboration with ViiV and the Clinton Health Access Initiative (CHAI), the product is expected to be launched in sub-Saharan Africa in late 2016, Aurobindo said.

ViiV and Aurobindo signed a licensing agreement in 2014 that allows Aurobindo to supply dolutegravir 50 mg in 92 licensed countries, after the completion of required local regulatory approvals.

“Dolutegravir is a critical new tool that will help us achieve the UNAIDS [Joint United Nations Program on HIV/AIDS] 90-90-90 goals and an AIDS-free generation,” commented David Ripin, executive vice president of CHAI. “The WHO included dolutegravir in its recommendations for first-line therapy in 2015, and we expect rapid growth in demand now that a cost-effective generic product is available. Dolutegravir, taken with other HIV treatments, has the potential to improve the lives of millions of patients.”

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