Serac Healthcare has been granted fast-track designation by the U.S. Food and Drug Administration (FDA) for the company's technetium-99m (Tc-99m) maraciclatide as a diagnostic SPECT-CT agent for lung imaging.
Specifically, the designation is for the visualization of inflammation in the lungs of patients with known and suspected interstitial lung disease (ILD).
The designation stems from results of phase-II preliminary data from the PRospective Evaluation of Interstitial Lung Disease progression with quantitative CT (PREDICT-ILD) trial, which showed that visualizing inflammation in people with fibrotic-ILD could be feasible with Tc-99m maraciclatide. Serac said further clinical results will be published later this year.
The company also highlighted that the fast-track designation will make way for faster approval, priority review, and more frequent meetings and written communication with the FDA for a drug development plan and proposed trials.
