Expanded Access, sometimes referred to as compassionate use, may be an option for certain individuals with serious or life-threatening conditions or diseases to gain access to an investigational medical product for treatment outside of clinical trials when there is no satisfactory or comparable alternative therapy to treat the disease or condition involved. Patients who qualify for a clinical trial on the Investigational Product requested are not eligible for Expanded Access.
For a full listing of Chiesi clinical trials, please visit www.clinicaltrials.gov. For more information on FDA guidelines, please click here.
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:
Requests for Expanded Access must be made by the patient’s treating physician. The treating physician must be actively licensed; fully qualified to administer the Investigational Product; willing to comply in writing to abide by any Chiesi requirements related to medical criteria, safety reporting, drug use and protection of intellectual property; committed and supportive of the requested treatment, and to have determined in his/her own judgement that the potential benefits outweigh the risks of treatment.
The treating physician may make the request for Expanded Access at https://chiesi.versaic.com. To submit a request for a Chiesi Rare Disease product please follow the instructions at Chiesi Global Rare Diseases or contact rareexpandedaccess@chiesi.com. Treating physicians are asked to avoid submission of any personal information (e.g. subject names) covered as protected health information in the initial Request for Expanded Access. Chiesi USA Medical Affairs, or someone acting on their behalf, will contact the treating physician in no more than five (5) business days of the request.
If you are seeking general information on expanded access for one of our products, please contact our medical information department here.
Each request will be reviewed on a case-by-case basis. Chiesi USA strives to make each decision comprehensively, reviewing all patient information submitted as well as the medical and scientific information available on the Investigational Product requested.
*Chiesi USA reserves the right to revise this Policy at any time. Expanded Access is not available in areas where forbidden by law or regulation including ruling by country or region specific regulatory bodies, importation requirements, and/or Ethics Committee or Institutional Review Board.