The FDA’s Antimicrobial Drugs Advisory Committee (AMDAC) met on November 16, 2017 to consider Bayer HealthCare’s NDA for ciprofloxacin inhalation powder for the reduction of exacerbations in non-cystic fibrosis bronchiectasis patients who have bacterial lung infections. After discussion, the members of the committee voted against recommendation of approval for both of the proposed regimens.
Among other issues, the FDA briefing document for the meeting noted that while the RESPIRE-1 trial demonstrated increased the time to the first exacerbation with a 14-day treatment regimen, the RESPIRE-2 trial did not show reduced time to first exacerbation for the 14-day treatment regimen. RESPIRE-2 also did not meet its primary endpoint, and the document questions the design of both trials.
In regard to the question, “Has the applicant provided substantial evidence of the safety and effectiveness for the ciprofloxacin dry powder inhaler (DPI) 14-day regimen in delaying the time to first exacerbation after starting treatment?”, the vote was 6 yes and 9 no.
In regard to the question, “Has the applicant provided substantial evidence of the safety and effectiveness for the ciprofloxacin DPI 28-day regimen in delaying the time to first exacerbation after starting treatment?”, the vote was 1 yes and 14 no.
Bayer’s ciprofloxacin DPI received orphan drug designation and QIDP status from the FDA in 2014.
View the AMDAC meeting materials.
