Eagle granted QIDP designation for CAL02 by FDA

Eagle Pharmaceuticals announced that the FDA has granted Qualified Infectious Disease Product, or QIDP, Designation under the Generating Antibiotic Incentives Now, or GAIN, Act and Fast Track Designation for CAL02, a first-in-class non-biological bacterial virulence neutralizer, anti-infective agent being developed to treat severe community-acquired bacterial pneumonia, or SCABP, as an add-on therapy to standard of care. “Receiving QIDP designation underscores the importance of CAL02 for potentially treating SCABP, and the Fast Track Designation allows us to work even closer with the FDA to bring patients a new treatment option sooner as we would also be eligible to request Priority Review for our application. Antibiotics alone, unfortunately, cannot win the war against pneumonia. CAL02 would serve as an add-on to standard of care antibiotic therapy for the prompt treatment of severe bacterial pneumonia and its devastating consequences,” stated Scott Tarriff, President and CEO. Eagle believes that CAL02 could also be eligible for breakthrough therapy designation. Eagle is also further developing the patent estate to protect the intellectual property resulting from the development of this novel, first-in-class therapy. CAL02 is currently protected by issued U.S. Patent No.10,744,089, which extends until September 2035, and may be eligible for Patent Term Extension for up to five years until 2040. SCABP is a worldwide prevalent infectious disease associated with high morbidity and mortality, despite the availability of vaccines, effective antibiotic regimens, and state-of-the-art critical care therapy.