FDA Panel to Consider Approval of Drug for Smoking-Related Lung Damage
A panel of the Food and Drug Administration (FDA) this week will meet to decide whether to recommend approval of a new drug for smoking-related lung damage, Fox News reports. The drug, Breo, is an inhaled treatment for chronic obstructive pulmonary disease.
It received a better-than-expected initial review from the FDA, documents on the agency’s website suggest. The FDA reviewers said the drug’s overall safety was consistent with similar drugs.
Investors were concerned the FDA might focus on an increase in the number of pneumonia cases in patients treated with the drug, the article notes. The panel was not in agreement about the drug’s effectiveness. They are scheduled to meet Wednesday.
If approved, Breo would compete with the drugs Advair and Symbicort.