Aerogen has received Fast Track Designation from the U.S. FDA for the Combination Product: Amikacin Pulmonary Delivery System for Ventilator-Associated Pneumonia (VAP).
The product is Aerogen’s lead drug/device combination product incorporating Aerogen’s OnQ Aerosol Generator technology adapted for high efficiency aerosol delivery to patients on mechanical ventilators.
The Fast Track Designation program was created to facilitate the development and expedite the review of a new product that is intended for the treatment of serious or life-threatening conditions, and demonstrates the potential to address unmet medical needs for such conditions. The FDA stated that it granted Combination Product: Amikacin Pulmonary Delivery System Fast Track designation for the following reasons:
1. VAP is a significant cause of morbidity and mortality in the intensive care unit (ICU), with an associated mortality rate of up to 50%. Patients with VAP have significantly longer duration of mechanical ventilation, ICU stay and hospital stay.
2. While Gram-negative organisms associated with VAP can be treated with aminoglycosides intravenously, parenteral delivery results in poor penetration of drug into the respiratory secretions and can cause significant adverse systemic effects. Targeted delivery of amikacin directly to the lungs takes advantage of the concentration-dependent killing of aminoglycoside antibiotics and has the potential to hasten resolution of the infection. The combination of high antibiotic concentrations at the infection site with low serum levels offers the possibility of reducing systemic toxicity.
“We are excited about the potential to significantly improve the treatment of patients with VAP using Aerogen’s aerosolized amikacin product and are delighted with FDA’s decision to grant Fast Track Designation for our program,” said Dr. Robert Fishman, Vice President of Scientific Affairs.
Murdok | Breaking eBusiness News
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