Qualified infectious disease product (QIDP) designation has been granted by the U.S. Food and Drug Administration (FDA) to two agents from Bayer – Ciprofloxacin Dry Powder for Inhalation (DPI) and Amikacin Inhale. QIDP designation refers to antimicrobial drugs conceived to treat serious and life-threatening infections. This designation qualifies the drug for fast-track designation, for priority review by the FDA and a five-year extension of market exclusivity.
Ciprofloxacin DPI corresponds to a combination of a drug and a device currently being evaluated for non-cystic fibrosis bronchiectasis (NCFB) therapy, a respiratory condition usually associated to a bacterial infection or other illness that injures the walls of the airways and can lead to severe lung infections. Bayer HealthCare has combined Ciprofloxacin DPI 32.5 mg (formulated with the Novartis’ PulmoSphere™ technology) with a portable, small manually breath-activated device – Novartis T-326 inhaler. Ciprofloxacin DPI is being tested to determine if inhalation for 28 days every other 28 days or for 14 days every other 14 days, over a period of 48 weeks, by NCFB patients can prolong the time to the first pulmonary exacerbation or reduce the frequency of exacerbations.
Amikacin Inhale is the result of a collaboration between Bayer HealthCare and the biopharmaceutical company Nektar Therapeutics. Amikacin Inhale (BAY 41-6551) corresponds to a combination of a drug and a device designed to act as an adjunctive therapy for patients with Gram-negative bacteria pneumonias who are intubated, mechanically ventilated and receiving standard of care intravenous antibiotics. This combination comprises the aerosolized Amikacin Inhalation Solution delivered by a Pulmonary Drug Delivery System (PDDS). Amikacin Inhale is currently being tested for its safety and efficacy in comparison with a placebo, being assessed in two forms: as an on-vent drug-device to be administered through a ventilator setting, and as an off-vent drug-device for non-intubated patients.
“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 the Vice President and Head of U.S. Medical Affairs at Bayer HealthCare Pharmaceuticals, Dr. Dario Mirski in a news release. “Bayer is committed to researching ways to deliver appropriate therapies to patients suffering from these very serious diseases.”
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