FDA Looks to Streamline Rules for New Drug Cocktails
Getting one drug through the FDA approval process is hard enough but getting the go-ahead for multiple medicines at once so they can be used together in so-called drug cocktails can be Herculean.
Now the agency is devising guidelines to speed up testing and approval of multidrug regimens for some of the world’s most deadly diseases, such as AIDS, tuberculosis and cancer, the WSJ reports this morning. Such a policy would be a first for the FDA, a spokesman says.
Two pharmaceutical consortia want to use the new approach, the article says. One is a group of 10 drug companies and several nonprofit organizations convened by the Bill and Melinda Gates Foundation to develop medicines to fight tuberculosis. The other is an effort by Merck and AstraZeneca, which are jointly testing two anticancer agents. Others may be interested as well.
Drug cocktails have been a big step forward in thwarting drug resistance because more mutations have to occur to block the effects of several drugs working together than are needed to escape just one medicine. Drug combinations also improve the chances of coming up with the mix that’s the most effective treatment.
As we know, cocktail therapies slashed the death rate from AIDS. […]
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