SATURDAY, OCTOBER 1, 2016

Sanofi Pasteur granted fast track by FDA for investigation of new drug

Sanofi Pasteur and KaloBios Pharmaceuticals announced on Tuesday that the U.S. Food and Drug Administration granted fast track designation to the investigation of KB001A.

KB001A is an antibody fragment that is used to fight bacterial pneumonia. This bacterial pneumonia is caused by Pseudomonas aeruginosa, which is commonly found in mechanically-ventilated patients.

"Sanofi Pasteur is currently targeting the antibody for use in primary prevention of Pa-associated pneumonia in mechanically ventilated patients in hospitals and we are also interested in providing prevention of relapses and improvement of treatment outcomes in patients with an ongoing Pa infection," Michel DeWilde, senior vice president of research and development, said. "Additional indications may be considered later in the lifecycle of the product."

Many Pa infections come from patients who are hospitalized and are in a critical condition. It mainly affects the respiratory system and may lead to serious complications and possibly death.

"Hospital-based pneumonias, especially those associated with mechanically ventilated patients in the ICU, are a life-threatening complication that can significantly increase mortality and morbidity as well as add tens of thousands of dollars to the cost of a hospital stay," David Pritchard, president and CEO of KaloBios, said. "KB001's novel mechanism of action against Pa may provide a unique means of fighting these infections, which are often resistant to antibiotic therapies."