The Food and Drug Administration (FDA)
on Thursday approved a generic version of Truvada, Gilead Sciences of
Foster City, California's blockbuster drug for HIV treatment and
pre-exposure prophylaxis (PrEP), which, when taken as prescribed,
lowers the chances of people at high risk for HIV from contracting
the disease.
Truvada is so far the only drug
approved for PrEP.
The announcement is considered a
breakthrough for PrEP advocates who see the drug's price ($1,500 a
month) as a barrier to increased adoption. A generic version of
Truvada could lower the cost by as much as 80 percent, Mitchell
Warren, executive director of AVAC, an HIV prevention group, told
Medscape.
In a
statement given to Poz,
Gilead said that “a generic version of Truvada will not be
immediately available.” Truvada is a combination of emtricitabine
and tenofovir. According to Gilead, the company's patent for
tenofovir expires next month but its emtricitabine patent does not
expire until 2021.
The FDA approval grants Teva
Pharmaceutical Industries of North Wales, Pennsylvania the right to
produce generic Truvada. A Teva spokesperson would not say when the
company's drug would hit the market.