Eagle Pharmaceuticals Receives FDA Qualified Infectious Disease Product (QIDP) and Fast-Track Designation for CAL02, Providing Five-Year Exclusivity Extension
Retrieved on:
Wednesday, June 14, 2023
Vaccine, Liposome, Patent, Priority review, Food and Drug Administration Safety and Innovation Act, QIDP, Marketing, Bronchopneumonia, Infection, End organ damage, Bacterial pneumonia, AB toxin, Eagle, Fast Track, Inflammation, The Lancet, Taxation of Chargeable Gains Act 1992, GAIN, United States patent law, Patient, NCE, Medicine, Disease, Mortality, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Pneumonia, Food, Pharmaceutical industry
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.
Key Points:
- 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.
- This treatment could represent a true paradigm shift and offer healthcare providers another option in combating this complex disease,” stated Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals.
- 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.