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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.
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.”
