The U.S. Food and Drug Administration (FDA) has approved a generic form of Teva Pharmaceutical’s Truvada, the drug used for HIV treatment and prevention (PrEP). It’s a move that has “taken HIV advocates by considerable surprise,” notes POZ.
The announcement signals major changes to come in the drug’s cost, both for insurance companies and individual consumers. Exact details regarding changes in price have yet to be determined. Currently, the monthly cost for Truvada can be upwards of $1,500 without insurance, and anywhere from $0 to $500 with insurance.
“Usually, it takes several generics before full cost-savings potential is reached,” Dr. Jeffrey S. Murray, deputy director of the Division of Anti-Viral Products at the FDA, told POZ. “Hopefully, this will help to expand PrEP availability for many.”
Generic forms of Truvada are already available on the market in other countries. In 2013, the FDA approved a generic form of the drug for limited use outside the U.S. during a White House AIDS relief program.
Like its non-generic counterpart, generic Truvada will come as a fixed-dose combination tablet.
The AIDS Vaccine Advocacy Coalition (AVAC) tweeted about the FDA’s decision:
Great news for #HIV #PrEP and #tx: @US_FDA approves first generic of drug for prevention of HIV and to treat HIV-1: https://t.co/HhkkFPsoC2— AVAC (@HIVpxresearch) June 9, 2017