The FDA has set its sights on a new and faster development pathway for drug cocktails, which could have a big impact on the therapeutic prospects for a slate of major diseases like cancer, AIDS, tuberculosis and hepatitis. And the Wall Street Journal reports that the initiative has helped inspire a major new development collaboration among pharma companies that will soon be announced.
"This represents a bigger issue--the strengthening of regulatory science" to encompass scientific advances, FDA Commissioner Margaret Hamburg told the Wall Street Journal, which details the new initiative in an in-depth article today.
Up to now the agency has taken a one-drug-at-a-time approach, with developers going on to demonstrate how approved products can work better for some diseases when combined. Complex ailments like cancer often have to be fought on several fronts, making drug cocktails more successful than single therapies.
This new initiative could accelerate collaborations among developers, which can share costs and science and hope to benefit from a faster approval process--and which could add huge amounts of additional sales revenue from approved products. The WSJ also says that the billionaire software entrepreneur Bill Gates inspired a coalition of drug companies to agree to collaborate on new cocktail therapies for tuberculosis, an initiative that will be announced later today.
- here's the story from the Wall Street Journal