It is two down and one to go for Truvada, the Gilead Sciences ($GLD) HIV medication. An FDA advisory panel, following the lead of the agency staff, recommended 19-3 that the drug be prescribed to people at high risk as a preventive against HIV infection.
Agency regulators will make the final call and decide on terms. That is expected to happen by June 15. The drug is already used for treating people infected with HIV, but the news moved Gilead's shares up 1.2% to $51.25 Thursday.
Truvada costs $14,000 a year, Bloomberg points out. But pit that against the 48,000 new cases of HIV that occur annually in the U.S., and the fact that those patients must then go on expensive regimens to treat the condition. There are 415,000 people in the U.S. considered by the Centers for Disease Control and Prevention to be at high risk of contracting HIV, mostly men having sex with men and spouses of people already infected.
In fact one expert voted against approval because there is no research to show the chances of kidney damage from the drug among one of the highest risk groups, black gay men, Reuters reports. "I don't think that is adequate when you're talking about the population that is most at risk," said Dr. Lauren Wood of the National Cancer Institute.
There is also concern about drug resistance if the drug is not taken as prescribed and if users don't also use condoms. Panel members believe that those getting it should be tested regularly.
For Gilead's part, Andrew Cheng, the company's senior vice president for HIV therapeutic and development operations, told the panel that the company will offer education, free HIV testing and condoms, and an assistance program for the uninsured, to help improve chances the drug will be used appropriately.
This is a big week for Gilead and its HIV drugs. Today, an advisory panel will rule on its Quad pill for treating HIV infections. Some analysts believe that Quad is more important for Gilead than Truvada.