bronchitol has to be approved

If you have a look/think about the CF drug therapy landscape (see the link below), and consider the efficacy of bronchitol, and its saftey profile, it ultimately has to be approved by the European Medical Association on appeal. Its shown to be twice as effective as saline in lung function baseline measures, and also better than Pulmozyme ($470 million selling drug). There are not allot of options to move the mucus, that causes all the problems.

The saftey issues highlighted by the EMA are a joke, when you compare them with recent approved antiobiotics including TOBI and even Pulmozyme. They are also a joke when you consider the drug showed 25% reduction in hospitalisation vs control (wheres the saftey issue here), which is not too far behind Pulmozyme.

Bronchitol has been shown to increase lung function by 7 to 8% in its 2 pivital studies. This compares with Pulmozyme which demonstrated 5.8% improvement way back in 1994. The only negative for Pharmaxis is the control in the bronchitol study (a low dose version of the drug)actually worked, so scientifically Bronchitol can only scientifically claim a 4% FEV1 (measure of lung function) improvement in its European study.

Since Pulmozyme gained approval in the 1990's medical specialists caring for the CF community have moved forward respiratory care considerably. This actually makes the Bronchitol data, even more compelling/impressive.

Bronchitol has to be approved on appeal in Nov/Dec 2011. It will be one a few decent tools medical specialists in the CF sector have to work with, as it moves the offending mucus better.


http://www.cff.org/research/DrugDevelopmentPipeline/