Compassionate Use and Expanded Access
According to the Food and Drug Administration (FDA), “Expanded Access, sometimes called Compassionate Use, is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.”
At Vivet Therapeutics, we are committed to developing a safe and effective therapy for Wilson’s Disease. Our investigational product, VTX-801, is currently in a Phase 1/2 clinical trial (GATEWAY trial) in order to understand the potential risks and benefits of this experimental drug. Without substantial scientific evidence to support the safety and efficacy of VTX-801, expanded or compassionate use access at this time is inappropriate.
If you have additional questions at this time, please speak with your physician or contact firstname.lastname@example.org