According to Bayer, its Amikacin Inhale inhalation solution and its ciprofloxacin DPI have both been granted qualified infectious disease product (QIDP) designation by the FDA. Both products are currently in Phase 3 development.
Bayer HealthCare Pharmaceuticals VP and Head Dario Mirski commented, “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. Bayer is committed to researching ways to deliver appropriate therapies to patients suffering from these very serious diseases.”
The company is developing Amikacin Inhale in partnership with Nektar, and the drug is delivered using Nektar’s Pulmonary Drug Delivery System (PDDS). The ciprofloxacin product uses Novartis’s PulmoSphere particle engineering technology with T-326 breath-activated inhaler and received orphan product designation from the FDA earlier this year.
Read the Bayer HealthCare press release.
