Expanded Access Policy
Expanded Access Policy
Pharvaris is committed to serving patients’ health needs by developing effective and safe therapies and making them available for use as quickly as possible. We believe that controlled clinical trials provide the best path for Pharvaris to generate the efficacy and safety information needed to obtain regulatory approval so that we can make our medicines available to all patients.
Pharvaris always seeks to provide the quickest and broadest access to its medicines, balancing benefit and risk to all patients. We support the principle of expanded-access programs consistent with the best standards for effective and safe use of an investigational therapy, as well as our ability to logistically provide a product. Pharvaris will consider requests for expanded access from qualified physicians, balancing multiple factors.
When evaluating potential use of an investigational therapy, we will consider several factors consistent with the U.S. Food and Drug Administration (FDA) and other regulatory agencies’ guidelines including both patient and scientific perspectives. Eligibility requirements include but are not limited to:
Sufficient scientific evidence to support both the efficacy and safety of the compound’s mechanism for this indication.
Sufficient scientific evidence to support both the efficacy and safety of the compound’s mechanism for this indication.
A serious or life-threatening illness, with no other satisfactory treatment options (such as approved products or enrolling clinical trials).
A serious or life-threatening illness, with no other satisfactory treatment options (such as approved products or enrolling clinical trials).
Sufficient evidence that the potential benefits to the patient would likely outweigh the potential risks, based on all available efficacy and safety information
Sufficient evidence that the potential benefits to the patient would likely outweigh the potential risks, based on all available efficacy and safety information
Support that providing the investigational drug will not interfere with clinical trials that could support the investigational drug’s development or regulatory approval for the treatment indication, which could affect future patient access.
Support that providing the investigational drug will not interfere with clinical trials that could support the investigational drug’s development or regulatory approval for the treatment indication, which could affect future patient access.
The evaluation of these, and other, questions may require additional investigation or interaction with the requesting physician, other clinical investigators, or regulatory authorities. Favorable answers alone provide no guarantee that Pharvaris will be able to provide pre-approval access to an experimental medicine.
Requests for access to investigational therapies must be made by a qualified and licensed physician to Pharvaris (expandedaccess@pharvaris.com) and will be evaluated by a review committee. Pharvaris anticipates it will acknowledge receipt of such requests within five business days after receipt of an inquiry. Pharvaris may revise this policy at any time.