Antibiotic makers have had a brutal year in front of the Food and Drug Administration. Over the last year, the agency has turned down the marketing applications for Wyeth's
It's difficult to tell exactly, but it looks like a random coincidence rather than a true crackdown on a treatment area as the diabetes drugmakers are experiencing. For instance, Theravance needs a Risk Evaluation and Mitigation Strategy (REMS) for approval while the agency asked Johnson & Johnson to audit the data from the clinical trials for ceftobiprole.
But maybe the tides are changing. Yesterday the FDA gave a green light to Wyeth's Tygacil -- yes, the same one that was rejected earlier. The drug was already approved to kill the bugs causing complicated intra-abdominal infections (cIAI) and complicated skin and skin structure infections (cSSSI) in patients. Now the FDA just approved it to treat community-acquired bacterial pneumonia (CABP).
My goodness -- cIAI, cSSSI, CABP -- those infectious disease docs really know how to give catchy names to the diseases they treat.
Long thought of as a dead treatment area, antibiotics are making a comeback thanks to superbugs that have become resistant to available treatments. Last year Cubist Pharmaceuticals'
Wyeth's approval is a nice start to resurrecting the approval of antibiotics (AoA). Maybe with AoA, FDA will CYA. (Certify Your Antibiotic, of course.)
More killer Foolishness:
- Geithner and Bernanke make a grab for more power.
- Raising dividends? Yee haw!
- Has Bernanke lost his marbles?
