Recently, two Bayer experimental drugs, Amikacin Inhale and Ciprofloxacin Dry Powder for Inhalation (DPI), were granted the title of qualified infectious disease products (QIDP) by the U.S. Food and Drug Administration (FDA). The QIDP designation was created from the Generating Antibiotic Incentives Now (GAIN) Act, approved in 2012 by the U.S. Congress to incentivize pharmaceutical companies to develop new drugs against microbes. The label of QIDP enables drugs that were developed to treat severe and life-threatening infections to be fast-tracked, get priority review by the FDA, and receive a five-year extension of market exclusivity.
Bayer worked in partnership with Nektar Therapeutics to develop Amikacin Inhale (BAY 41-6551), which works as an adjunctive therapy for patients with Gram-negative pneumonias who are intubated and mechanically ventilated. This drug is being evaluated in two configurations, an on-vent drug-device to be administered through a ventilator setting, and an off-vent drug-device for non-intubated patients.
Ciprofloxacin dry powder for inhalation (DPI) is a combination drug that includes 32.5 mg of Ciprofloxacin developed using PulmoSphere™ technology from Novartis and a device, the Novartis T-326 inhaler, a small, breath-activated device manually portable. This drug is being evaluated as a therapy for non-cystic fibrosis bronchiectasis (NCFB) by Bayer HealthCare. The DPI is being tested in patients with non-cystic fibrosis bronchiectasis to assess its potential to delay the time of the first pulmonary exacerbation of bronchiectasis episode or to reduce its frequency. The schedule of treatment for patients with non-cystic fibrosis bronchiectasis will be inhaled ciprofloxacin for every other 14 or 28 days during 48 weeks days other 14 days over 48 weeks, in patients with 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, U.S. Medical Affairs, Bayer HealthCare Pharmaceuticals, in a press release. “Bayer is committed to researching ways to deliver appropriate therapies to patients suffering from these very serious diseases,” concluded Dr. Mirski.