The Food and Drug Administration, on June 5, granted approval to a generic version of Truvada, a medication that has been used as a Pre-Exposure Prophylaxis ( PrEP ) intervention to prevent HIV infection.
The FDA granted Israel-based Teva Pharmaceuticals the right to manufacture the first generic version of Truvada. The patent on the formula for Truvada's components does not expire until 2021, so HIV/AIDS advocates and service-providers were not expecting a generic configuration of the drug much sooner than that.
Poz reported June 9 that both Teva and Foster-City, California-based Gilead Sciences, Inc., which manufactures Truvada, that a release date for the generic version was not planned for the short-term future, however.
"A generic version of Truvada will not be immediately available," said Gilead's statement to Poz. "It's important to note that there are a number of factors involved in commercialization that are not tied directly to FDA approval."
While taking Truvada, which is also used in treatment for persons with HIV, has been shown to reduce the likelihood of HIV-infection by over 90 percent, its widespread use has been inhibited in part by an extremely high price tag: The drug can cost upwards of $1,600 for a 30-day supply. Many public agencies and service providers have launched initiatives to encourage its use, but there has been limited success in reaching populations especially at risk for infection, among them young MSM ( men who have sex with men ) of color and transgender women.
Human Rights Campaign released a statement June 9 encouraging fast action from the pharmaceutical firms, further noting that Gilead needed to continue to offer assistance programs for consumers who could not afford the high prices.
"While the timeline is uncertain for when a generic drug will be available to consumers, today's decision by the FDA is a much-needed breakthrough in our ongoing efforts to expand HIV prevention options, especially for those most vulnerable to HIV and AIDS" said Mary Beth Maxwell, HRC senior vice-president for programs, research and training. "Despite growing use of PrEP nationally, the drug remains out-of-reach for many in the communities hardest hit by the epidemic, including young gay and bisexual men and transgender women of color. We implore Gilead to continue their critical payment assistance programs and urge other companies to provide similar financial relief."
Poz's article is at Poz.com/article/fda-approves-generic-truvada.
