FDA Panel Recommends HIV Drug's Approval
An advisory panel to the U.S. Food and Drug Administration has unanimously recommended that the full agency approve Merck & Co.'s HIV drug Isentress (raltegravir) for people who are running out of treatment options, the Associated Press reports.
Isentress is among a new class of antiviral drugs called integrase inhibitors, which target an enzyme that allows the AIDS-causing virus to infect cells and reproduce itself. It's meant to be included among a "cocktail" of medications to combat HIV in people who have become resistant to other medications, the wire service said.
In two recent trials, the drug "reduced the virus to almost undetectable levels" after four months in as many as 62 percent of patients who took it in combination with other HIV medications, the Bloomberg news service said. That compared with up to 36 percent of patients who took a non-medicinal placebo along with the other HIV treatments.
A decision about Isentress from the full FDA is likely by next month. While the agency isn't bound by the recommendations of its expert panels, it usually follows them.
Britain to Allow Creation of Hybrid Embryos
The British agency that oversees human embryo research is prepared to permit creation of embryos for experimental use that are part human, part animal, the Washington Post reports.
Researchers hope to determine whether such hybrid embryos could yield embryonic stem cells that may aid them in developing therapies for diseases such as Parkinson's and Alzheimer's. The embryos would be created by injecting human DNA into cow or rabbit eggs, whose own DNA has mostly been removed, the newspaper said.
Currently, embryos used for research generally have come from women treated with hormones. But in order to harvest stem cells, these embryos must be destroyed, which has raised ethical concerns.
In 2001, U.S. President George Bush limited federal funding for research to only stem-cell lines that existed at the time. Researchers have since found that many of those lines are contaminated.
The new ruling by Britain's Human Fertilisation and Embryo Authority said it acknowledged the concerns of opponents who feared "the specter of rogue scientists growing the embryos into weird human-animal creatures," the Post reported.
In a statement, the agency said the decision was not "a total green light" for hybrid research, "but recognition that this area of research can, with caution and careful scrutiny, be permitted."