Chiesi USA

Single-Patient EA Policies/Criteria Chiesi USA’s stated goals include the development of pharmaceutical solutions to improve the quality of human life and to combine commitment to result with integrity, operating in a socially responsible manner. In line with the Chiesi Mission and our core values, Chiesi USA will consider granting access to patients whenever possible who meet the following criteria: - The patient has a serious or life-threatening illness with no comparable or satisfactory alternative therapies. - The patient is ineligible for, or otherwise unable to, participate in a clinical trial related to the Investigational Product requested. Geographical limitations related to investigational product access will not necessarily render expanded access subjects ineligible. - In the treating physician’s judgement, the potential patient benefit justifies the potential risks of the treatment use and those potential risks are not unreasonable in the context of the disease or condition to be treated. - The Investigational Product is currently being studied in humans. - Adequate supply exists or can be produced to support both the ongoing clinical investigations and compassionate use. - Providing the Investigational Product for the requested use will not interfere with the initiation, conduct, or completion of clinical investigations that could support FDA approval of the expanded access use or otherwise compromise the potential development of the expanded access use. Available Therapies via Single-Patient EA Pegunigalsidase alfa for Fabry disease