news

  • 1 December 2016
    Arsanis Receives FDA Fast Track Designation for ASN100 for the Prevention of Staphylococcus aureus Pneumonia

    Arsanis, Inc., a clinical-stage biopharmaceutical company developing targeted monoclonal antibodies (mAbs) for pre-emptive and post-infection treatment of serious infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ASN100 for the prevention of Staphylococcus aureus pneumonia in mechanically ventilated patients who are at high risk for S. aureus pneumonia.

    Fast Track designation is intended to facilitate the development and expedited FDA review of drugs to treat serious or life-threatening conditions and address unmet medical needs.

    “Despite current antibiotic treatments, S. aureus pneumonia has a mortality rate as high as 30 percent in this patient population1 ,” said René Russo, Pharm.D., BCPS, Chief Executive Officer, Arsanis. “We are pleased that the FDA has granted Fast Track designation to ASN100 to prevent S. aureus pneumonia in high-risk, mechanically ventilated patients, and we look forward to working closely with the Agency as we continue the development of our lead monoclonal antibody program for this vulnerable patient population.”