US FDA gives tentative approval for Aurobindo's generic HIV drug
Aurobindo Pharma Limited announced on Thursday that it has received tentative approval from the US Food and Drug Administration (US FDA) for Dolutegravir 50 mg.
This is the first FDA approval for a generic version of Dolutegravir, an integrase inhibitor recommended for use in treatment of HIV patients by the US Centers for Disease Control and Prevention and the World Health Organisation (WHO).
The approved abbreviated new drug application is bioequivalent and therapeutically equivalent to the reference listed drug product Tivcay of ViiV Healthcare. The product is expected to be launched in sub-Saharan Africa in late 2016 through an innovative collaboration with ViiV and the Clinton Health Access Initiative, Inc, according to the company.
ViiV Healthcare and Aurobindo Pharma signed a licensing agreement in 2014 that allows the company to supply Dolutegravir 50 mg in 92 licensed countries, following completion of required local regulatory approval processes.
"The approval of the generic version of DTG shows the commitment towards the larger cause of bringing affordable HIV drugs to millions of people. 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," N Govindarajan, managing director of Aurobindo Pharma said.
WHO included Dolutegravir in its recommendations for first-line therapy in 2015. "We expect 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," David Ripin, executive vice-president of the Clinton Health Access Initiative, said.