An advisory committee is recommending against US regulatory approval of a mist formulation that Aradigm developed to deliver an antibiotic for the Pseudomonas aeruginosa lung infections in bronchiectasis.
Although the US Food and Drug Administration can reject the recommendation against Linhaliq, an inhaled form of ciprofloxacin, it will consider the advisers’ views in its decision. The treatment is for bronchiectasis that is not associated with cystic fibrosis. The FDA decision is expected no later than Jan. 26.
“While we are disappointed with the outcome of the ADAC [Antimicrobial Drugs Advisory Committee] vote, we remain confident in the efficacy, safety and tolerability of Linhaliq in NCFBE [non-cystic fibrosis bronchiectasis] patients,” Igor Gonda, the president and CEO of Aradigm, said in a press release.