News Feature | November 26, 2014

Bayer Wins 2 FDA QIDP Designations For Inhaled Drugs

By Estel Grace Masangkay

Bayer announced that it has received two Qualified Infectious Disease Product (QIDP) designations from the U.S. Food and Drug Administration (FDA) for two of its inhaled investigational drugs, Amikacin Inhale and Ciprofloxacin Dry Powder for Inhalation (DPI).

Amikacin Inhale (BAY 41-6551) is being developed by Bayer in collaboration with Nektar Therapeutics as an adjunct therapy for patients with Gram-negative pneumonias who are intubated and mechanically ventilated. Amikacin Inhale contains Amikacin Inhalation Solution delivered by a Pulmonary Drug Delivery System (PDDS). The product is being investigated in a late-stage trial and is being pitted up against aerosolized placebo as treatment for patients receiving standard-of-care IV antibiotics for their disease.

Ciprofloxacin DPI is an investigational drug being developed for non-cystic fibrosis bronchiectasis (NCFB). The company is developing a formulated version of ciprofloxacin to be used with Novartis’ T-326 inhaler. The product is also being investigated in a late-stage clinical trial. Earlier this year, the FDA has granted Orphan Drug Designation to ciprofloxacin DPI in NCFB.

Dario Mirski, VP and Head of the U.S. Medical Affairs division of Bayer HealthCare Pharmaceuticals, said, “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.”

The QIDP status gives Bayer’s drugs eligibility for fast track status, priority review, and a five-year extension of market exclusivity. The designations will allow the company to interact more extensively with the agency for the development of the drug candidate and will expedite the review process for its application.

Earlier this month, Bayer also announced that it has begun the mid-stage trial of another drug that targets fibrosis. Riociguat is an investigational treatment for patients with diffuse cutaneous systemic sclerosis (dcSSc).