Bayer HealthCare has received the US Food and Drug Administration (FDA) qualified infectious disease product (QIDP) designation for its two investigational agents, Amikacin inhale and Ciprofloxacin dry powder for inhalation (DPI). The QIDP designation was established as part of the Generating Antibiotic Incentives Now (GAIN) Act, passed by the US Congress in July 2012 to encourage pharmaceutical companies to develop new antimicrobial drugs.
Antimicrobial drugs designed to treat serious and life-threatening infections, designated as QIDP, are eligible for fast-track designation, priority review by FDA and a five-year extension of market exclusivity. Amikacin inhale is being developed by Bayer HealthCare in collaboration with Nektar Therapeutics.
Amikacin Inhale (BAY 41-6551) is being investigated to evaluate the efficacy and safety of adjunctive aerosolized amikacin inhalation solution versus aerosolized placebo in the treatment of intubated and mechanically ventilated adult patients with Gram-negative pneumonia receiving standard of care intravenous antibiotics. Ciprofloxacin DPI is being investigated to evaluate if the time to first pulmonary exacerbation of bronchiectasis can be prolonged, or its frequency reduced, by inhalation of ciprofloxacin for 28 days every other 28 days, or for 14 days every other 14 days over 48 weeks, in patients suffering from non-cystic fibrosis bronchiectasis.
"We welcome the QIDP designation for Ciprofloxacin DPI and Amikacin Inhale, as we continue investigating the safety and efficacy of their use in delivering anti-infective therapy directly to the lungs of patients suffering from non-cystic fibrosis bronchiectasis and intubated and mechanically ventilated patients suffering from Gram-negative pneumonia respectively," said Dario Mirski, MD, vice president and Head, US Medical Affairs, Bayer HealthCare Pharmaceuticals. "Bayer is committed to researching ways to deliver appropriate therapies to patients suffering from these very serious diseases."
Amikacin Inhale (BAY 41-6551), is the development name for an integrated drug-device combination, developed by Bayer HealthCare in collaboration with Nektar Therapeutics as an adjunctive therapy for intubated and mechanically ventilated patients with Gram-negative pneumonias. It comprises Amikacin Inhalation Solution delivered by a Pulmonary Drug Delivery System (PDDS). Amikacin Inhale is being investigated in two configurations, an on-vent drug-device that works within the ventilator setting, and an off-vent drug-device for extubated patients.
Ciprofloxacin dry powder for inhalation (DPI) is the development name of a drug-device combination currently being investigated in non-cystic fibrosis bronchiectasis (NCFB) by Bayer HealthCare. It combines Ciprofloxacin DPI 32.5 mg (formulated using Novartis' PulmoSphere technology) with the Novartis T-326 inhaler, a small, portable manually breath-activated device.