FDA support for FLUIDDA’s FRI-technology in lung fibrosis
The US Food and Drug Administration has issued a letter of support for FLUIDDA’s Functional Respiratory Imaging (FRI) technology. The FDA encourages the use of FRI in clinical trials with patients suffering from Idiopathic Pulmonary Fibrosis (IPF).
IPF is characterized by the creation of scar tissue in the lungs that progressively reduces the capacity to properly move oxygen into the bloodstream. The median survival of patients with IPF is dramatic: only 2 to 3 years of life remain after diagnosis. The development of therapeutics for the disease is seriously hampered by the lack of biomarkers to use as clinical end points. Presently, no qualified markers are available to measure disease progression or treatment benefit.
FLUIDDA’s FRI-technology provides structural and functional information of the lung, derived from conventional low-dose CT scans. FRI is a promising tool to be used by pharmaceutical and biotech companies to expedite the development of new drugs. FRI has already proven its merit in lung disorders such as asthma and COPD. The FDA now highly recommends its use in the search for and development of better IPF biomarkers.
FLUIDDA’s CEO Dr. Jan De Backer states: “This is an important milestone for our company. Having the support of the FDA in the development of new biomarkers is crucial to facilitate further adoption of our technology. We are looking forward to continuing our collaboration with pharmaceutical and biotech companies who are committed to developing new and better drugs for this terrible disease.”
Read the FDA’s full letter of support here.