Gilead Sciences Inc. (GILD) Thursday filed a supplemental New Drug Application with the US Food and Drug Administration seeking approval of its blockbuster HIV drug Truvada for reducing the risk of the disease occurring through sex in uninfected adults.
Truvada was approved by the FDA in 2004 for the treatment of HIV-1 infection and is currently the most-prescribed antiretroviral treatment in the US, Gilead said. In its third quarter, Gilead reported Truvada sales of $744.7 million, up 11 percent from last year, on growth in Europe and the US.
If the sNDA is approved, Truvada would be the first agent indicated for uninfected individuals to reduce the risk of acquiring HIV through sex, a prevention approach called PrEP.
According to current Centers for Disease Control and Prevention data, each year some 50,000 people are newly infected with HIV in the US. Truvada is not currently indicated to reduce the risk of HIV infection.
Truvada sNDA is based on results of two large Phase 3 trials, sponsored by the US National Institutes of Health and the University of Washington respectively.
"The data from these large-scale clinical trials suggest that Truvada may have a role to play in meeting the urgent public health need to reduce new HIV infections," said Gilead CEO John Martin.
Elaborating on the trials, Gilead said that in one study, known as the Pre-Exposure Prophylaxis Initiative (iPrEx), which involved 2,499 high-risk HIV-negative homosexuals in the US and other countries, the once daily use of Truvada reduced the risk of acquiring HIV by 44 percent compared with placebo and by up to 73 percent in men who took the drug consistently. In men with enough detectable drug presence, the risk was reduced by more than 90 percent.
The other trial, Partners PrEP, involved 4,758 heterosexual couples in Kenya and Uganda in which only one partner was infected with HIV. Results showed that once-daily use of oral Truvada by the HIV-negative participants reduced their risk of acquiring HIV by 73 percent compared with placebo.
In all studies, side effects included nausea, weight loss and serum creatinine elevations, and were consistent with Truvada's safety and tolerability profile when used as HIV treatment.
GILD closed Thursday's session on the Nasdaq at $38.49, down $0.27 or 0.70%. In after hours, the stock gained $0.50 or 1.30%.
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