Revolo Biotherapeutics is committed to the development and commercialization of targeted medicines that have the potential to change the standard of care, including quality of life, for patients who suffer from serious or life-threatening diseases.
Before our investigational medicines can be made broadly available, the U.S. Food and Drug Administration (FDA) and other worldwide health authorities require that they are studied in controlled clinical trials to determine if they are safe and effective. At Revolo, our focus is on enrolling patients in clinical trials to obtain the data required for review and approval by these regulatory authorities. People who take part in clinical trials play important roles in the development of new treatments.
Therefore, participation in Revolo Biotherapeutics’ clinical trials is currently the only pathway for patients to gain access to our investigational therapies, and we do not offer compassionate use nor expanded access programs at this time. The safety and well-being of patients are of paramount importance to us. The investigational nature of our treatments requires stringent adherence to clinical trial protocols, which have been designed to carefully assess safety and efficacy. We believe this approach will lead to broader patient access in the future.
As authorized by the 21st Century Cures Act, Revolo Biotherapeutics may revise this expanded access policy at any time. Additionally, the posting of this policy by Revolo Biotherapeutics shall not serve as a guarantee of access to any specific investigational drug for any patient.
For more information on our clinical trials, search “Revolo Biotherapeutics” at www.clinicaltrials.gov.
For more information from the FDA about expanded access in the United States, visit: www.fda.gov/news-events/public-health-focus/expanded-access.