Sometimes called “compassionate use”, expanded access is a potential pathway for a patient with a serious or immediately life-threatening 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.
Expanded access may be appropriate when all the following apply:
• Patient has a serious or immediately life-threatening disease or condition.
• There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.
• Patient enrollment in a clinical trial is not possible.
• Potential patient benefit justifies the potential risks of treatment.
• Providing the investigational medical product will not interfere with investigational trials that could support a medical product’s development or marketing approval for the treatment indication.
Investigational drugs, biologics or medical devices have not yet been approved or cleared by FDA; therefore, their potential risks and benefits are not yet established. Furthermore, the investigational medical product may, or may not, be effective in the treatment of the condition, and use of the product may cause unexpected serious side effects.
As a general policy, Agomab Therapeutics will not provide investigational medicines to patients until a dose and schedule has been established for the agent, preliminary data exists that that investigational drug has some evidence of activity in a particular indication and is found to be safe as a result of a risk-benefit evaluation.
Because its investigational drugs are in preclinical or early clinical development stages, Agomab Therapeutics believes that participation in one of our clinical trials is the most appropriate way to access our investigational therapies. Agomab Therapeutics continues to assess the eligibility requirements and criteria for Expanded Access to its investigational drugs and will re-evaluate this policy from time to time.
“Our pipeline will continue to grow with the addition of both novel antibody and small molecule drug candidates that we are designing with the goal of bringing a range of truly disease-modifying treatments to patients in need.”
Philippe Wiesel, Chief Medical Officer