PhaseBio is willing to provide our investigational drug products to patients for the treatment of serious or life-threatening diseases or conditions in compliance with FDA Expanded Access (Compassionate Use) Policies provided the following criteria are met:
- The request must be made by the patient’s treating physician, who must agree to comply with the company’s safety and monitoring requirements. The patient must agree to provide access to their data for use by PhaseBio in support of drug development activities.
- Sufficient evidence of the safety and effectiveness of the investigational product is available to support its use in the particular patient population. Safety information must also be available to support patient use in an environment less controlled than a sponsored clinical trial. Typically, this will be after at least phase 2B data are available.
- The probable risk to the patient from the investigational product is shown to be not greater than the probable risk from the disease or condition.
- Providing investigational products does not delay progression of the clinical development program and the ultimate goal to provide patients with access to approved, safe and effective drugs.
- Adequate drug supply is available to support expanded access in addition to any ongoing clinical study supply needs.
- There is no comparable or satisfactory therapy (approved or investigational) available to treat the patient’s disease or condition.
- The patient is unable to participate in a clinical trial based on the trial’s inclusion and exclusion criteria, or if participation in the study is not geographically feasible.
When PhaseBio product candidates are in an early stage of development and do not meet these criteria, we will only be able to offer our investigational products to patients participating in controlled clinical studies. We encourage participation in a clinical study as this will enable us to progress development to a stage where we will be able to offer these investigational products for expanded access. Please check ClinicalTrials.gov for ongoing clinical studies. As we continue to develop our clinical pipeline, we encourage you to check back for updates regarding investigational drugs which meet the criteria for expanded access.