epocrates
Nasal spray cleared for expanded use in Alzheimer’s
The FDA cleared foralumab, an investigational anti-CD3 monoclonal antibody nasal spray, for expanded use* to treat moderate Alzheimer’s disease. According to a press release from manufacturer Tiziana Life Sciences, the drug demonstrated a favorable safety profile and clinical response in patients in studies to date. Foralumab works by binding to the T-cell receptor and dampening inflammation by modulating T-cell function. Tiziana is also testing foralumab for other neurodegenerative diseases, such as multiple sclerosis (MS) and is planning a phase 2 study in adults with nonactive secondary progressive MS.
*An expanded use program (AKA compassionate use program) allows patients access to an unapproved medication outside clinical testing when all other available options have been exhausted or found to be ineffective.
Source:
Maia, M. (2024, July 11). Tiziana Life Sciences. FDA clears foralumab nasal spray for expanded use in Alzheimer’s. https://www.tizianalifesciences.com/fda-clears-foralumab-nasal-spray-for-expanded-use-in-alzheimers/