FDA Advisory Committees - FDA Center for Drug Evaluation and Research (CDER) - Antimicrobial Drugs Advisory Committee (AMDAC)
The Committee will discuss a new drug application for ciprofloxacin inhalation powder, sponsored by Bayer HealthCare Pharmaceuticals, Inc., for the proposed indication of reduction of exacerbations in non-cystic fibrosis bronchiectasis (NCFB) adult patients (≥18 years of age) with respiratory bacterial pathogens.
The Committee discussed the development of antibacterial drugs that treat a single species of bacteria when the target species infrequently causes infections. Overall, the Committee supported the conduct of non-inferiority trials with expanded margins to support approval. The Committee did not support the use of data obtained from studies of animal models as a sole basis for approval.
The Committee narrowly supported, by a vote of 7-Yes to 6-No, with no abstentions, the safety and efficacy of solithromycin capsules and solithromycin for injection, sponsored by Cempra Pharmaceuticals, Inc. (Cempra), for the proposed indication of the treatment of community-acquired bacterial pneumonia (CABP).
The Committee supported, by a vote of 10-Yes to 5-No, with 1 abstention, the safety and efficacy of Merck’s bezlotoxumab for the proposed indication of the prevention of Clostridium difficile infection (CDI) recurrence in patients aged 18 years and older.
The Committees voted unanimously (21 of 21 members) that the benefits and risks of the systemic fluoroquinolone antibacterial drugs do not support the current labeled indication for the treatment of acute bacterial sinusitis (ABS). Approved fluoroquinolone drugs include levofloxacin (Levaquin), ciprofloxacin (Cipro), moxifloxacin (Avelox), norfloxacin (Noroxin), ofloxacin (Floxin), and gemifloxacin (Factive).
Past AIDAC Meetings
On Thursday, January 22, 2015 the Anti-Infective Drugs Advisory Committee (AIDAC) unanimously supported, by a vote of 11-Yes to 0-No, the safety and efficacy of isavuconazonium sulfate capsules and isavuconazonium sulfate for injection, sponsored by Astellas Pharma Global Development, Inc. (Astellas), for the proposed indication of the treatment of invasive aspergillosis.
The AIDAC supported, by a vote of 8-Yes to 2-No, with one abstention, the safety and efficacy isavuconazonium sulfate capsules and isavuconazonium sulfate for injection, by Astellas, for the proposed indication of the treatment of invasive mucormycosis.
Antimicrobial Drugs Advisory Committee (AMDAC)
Antimicrobial Drugs Advisory Committee (AMDAC) formerly known as the Anti-Infective Drugs Advisory Committee (AIDAC).
The Committee reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of infectious diseases and disorders and make appropriate recommendations to the Commissioner of Food and Drugs.