Two Bayer Inhaled Antibiotics Granted US FDA QIDP Designation
Bayer HealthCare, a global leader in respiratory medicine, recently announced it has received qualified infectious disease product (QIDP) designation from the US Food and Drug Administration for two pipeline inhalation antibiotic drugs: Amikacin inhale and Ciprofloxacin dry powder. The approval of novel inhaled antibiotics are of particular interest to the CF community, as recurrent bacterial infections of the lung are potentially deadly for those with the disease.
The QIDP was created in line with Congress’ Generating Antibiotic Incentives Now (GAIN) Act, passed July 2012, which aims to encourage pharmaceutical companies to devote research and development efforts to newer and better antimicrobial treatments for serious infections. This designation grants the product eligibility for a Fast Track designation, priority review from the agency and a potential 5-year extension of market protection once launched.
“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)
Bayer is co-developing Amikacin Inhale with clinical stage biopharmaceutical company Nektar Therapeutics as a drug-device combination administered via a Pulmonary Drug Delivery System (PDDS). The drug’s safety and efficacy as an adjunct aerosol treatment in intubated or mechanically-ventilated patients with Gram-negative pneumonia, receiving standard IV antibiotics, is currently under evaluation. The inhalation drug will come in two formulations: as an on-vent drug-device for ventilators, and an off-vent drug-device for extubated patients.
Ciprofloxacin DPI is being evaluated for its ability to inhibit bronchiectasis exacerbation or reduce frequency of pulmonary attacks when inhaled for 28 days every other 28 days, or for 14 days every other 14 days for 48 weeks. Bayer plans to offer ciprofloxacin DPI as a drug-device combination indicated for the treatment of non-cystic fibrosis bronchiectasis (NCFB). 32.5 mg of the drug will be administered via the Novartis T-326 inhaler, a hand-held, breath-activated device.
In other developments for respiratory infections, a group of researchers may have found a way to boost immune function in cystic fibrosis patients’ lungs. Interleukin-26 has shown to play a key role in mediating pulmonary immune response to bacterial infections by stimulating nearby neutrophils to mobilize and neutralize bacteria.