Pharvaris

Single-Patient EA Policies/Criteria Pharvaris is committed to serving patients’ health needs by developing safe and effective 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 safety and efficacy 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 safe and effective 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 US Food and Drug Administration (FDA) and other regulatory agencies’ guidelines including both patient and scientific perspectives. Eligibility requirements include but are not limited to: 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 core team. Pharvaris anticipates it will acknowledge receipt of such requests within five business days after receipt of an inquiry.