The best news from this week’s FDA Anti-Microbial Advisory Committee meeting was that there are a lot of meetings. A busy committee means that they have more antibiotics to review. The race against drug-resistant superbugs has reduced incentives for drug companies to develop antibiotics. These drugs cost as much to develop as others but are out-of-date too soon as bacteria develop resistance to the new drug. And the product is meant to be used sparingly; overuse of antibiotics is one of the factors that led to superbugs. The economics just don’t work. So a busy committee is good news.
This week’s meeting centered on ALIS, the first potential treatment for Nontuberculosis Mycobacterial Lung Disease. This odd sounding condition affects over 80,000 people and is very difficult to treat with current antibiotics. The bug is commonly found in soil and water. Most people brush off the bug easily but some don’t, leading to a chronic, life-threatening infection. In contrast to current oral treatments with serious side effects, the new drug is inhaled so it’s better tolerated by fragile patients. ALIS is over four times more effective at treating the infection than current treatments, but 70% of patients are still infected after the new treatment. Results of the only test of health outcomes for the new treatment, how far a patient can walk in six minutes, were unclear. The committee urged better clinical and patient-reported outcome measures in future research.