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Biotech Bombshell?

Foster City-based Gilead Sciences wants FDA approval for breakthrough AIDS drug.

A Foster City-based biotech behemoth on Thursday officially sought approval from a federal agency for a breakthrough drug that appears to be the closest thing to an AIDS vaccine ever developed.

Gilead Sciences announced that it submitted an application to the Food and Drug Administration seeking approval for “Truvada,” a once-daily pill the company says reduces the risk of infection. 

Truvada would be the first such preventative AIDS drug to be approved by the FDA.

The word “vaccine” does not appear anywhere in a 2,585-word press release company press release issued Thursday, however the medication is described by the San Jose Mercury News as “a significant milestone in the battle against AIDS.”

Among the participants in a clinical trial who took the drug consistently enough to have a detectable amount of the drug in their body, the risk of acquiring HIV was reduced by 90 percent.

Gilead said 2,499 high-risk HIV negative adult men in the United States, Africa, Asia and South America participated in the study.

"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,” Gilead CEO John C. Martin said in a prepared statement.

A leading AIDS advocacy expert described Gilead’s work as a revelation, the Mercury reported.

"This is really an exciting moment," Mitchell Warren, executive director of the AIDS Vaccine Advocacy Coalition told the Mercury. "The implications are huge."

According the Centers for Disease Control and Prevention, 50,000 people are infected with HIV virus in the United States each year.

"This year marked the 30-year milestone of the AIDS pandemic and the loss of an estimated 30 million lives, but it has also been a year of hope with several significant new advances in antiretroviral-based HIV prevention," said Connie Celum, a Professor of Global Health and Medicine at the University of Washington and lead investigator in the Truvada trial.

The HIV incidence rate has remained steady for many years despite widespread public knowledge of how the disease is spread.

More than half of new infections (61 percent) occur among men who have sex with men, and nearly a quarter (23 percent) occur among women.

"It is clear that new prevention strategies are urgently needed to tackle the unacceptably high number of new HIV infections in the United States," a team of scientists involved in the trial said in a joint prepared statement.

Truvada’s efficacy, however, hasn’t been universally embraced.

Bloomberg earlier this year reported that a clinical trial was cancelled after some of the early returns suggested the drug was useless in preventing the contraction of HIV among women.

Of the 56 participants in the study who contracted the AIDS virus, half took Truvada and other half a placebo.

“At this time, it cannot be determined whether or not Truvada works to prevent HIV infection in women,” Family Health International, a nonprofit group that sponsored the study, told Bloomberg.

Gilead spokeswoman Amy Flood acknowledged the findings to be a setback, but told Bloomberg her company was committed to developing of Truvada.

“While this development was not what we would have hoped for, Gilead believes that antiretroviral therapies remain a promising potential HIV prevention strategy,” Flood said. “We continue to support ongoing studies evaluating the company’s antiretroviral therapies as potential preventatives.”

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