Censa Pharmaceuticals is focused on developing CNSA-001 (sepiapterin) for the treatment of phenylketonuria (PKU) and other diseases associated with defects in the tetrahydrobiopterin biochemical pathways.
Expanded access, also called compassionate use, refers to a pathway in which patients with serious or immediately life-threatening diseases may gain access to an investigational therapy outside the context of participation in clinical trials designed to evaluate safety and efficacy. The following is Censa Pharmaceutical’s expanded access policy for investigational drugs that are intended to treat serious diseases.
Censa Pharmaceuticals believes that investigational drugs should be studied in patients as part of clinical trials designed to obtain data on safety and efficacy that may be used to support approval of the product which would lead to subsequent wider availability for patients. Censa Pharmaceuticals strongly encourages patients to speak with their treating physicians and when possible, to participate in clinical trials. Censa Pharmaceuticals is aware that in rare cases patients with serious life-threatening diseases are unable to participate in clinical trials and may have exhausted all available therapies. In these rare cases, Censa Pharmaceuticals may consider providing an investigational product outside of a clinical trial. At this time, we do not have an expanded access program that allows patients to have access to our investigational products prior to FDA approval.
At this time Censa Pharmaceuticals does not have any investigational product candidates available for expanded access. If you have any questions about our investigational product candidates or expanded access policy, please contact Censa Pharmaceuticals through the following email address: firstname.lastname@example.org.
Censa Pharmaceuticals is not currently making its investigational products available on an expanded access basis anywhere in the world. In the event that Censa Pharmaceuticals decides to consider making one or more of its investigational products available through an expanded access program, requests for expanded access to Censa Pharmaceuticals investigational products must come from the patient’s treating physician.
TIMING OF ACKNOWLEDGEMENT
Censa Pharmaceuticals anticipates that it will acknowledge receipt of any expanded access questions or requests within five to ten business days of receipt.
As stated above, Censa Pharmaceuticals is not currently making its investigational product candidates available for expanded access use anywhere in the world. In the event that Censa Pharmaceuticals decides to make its investigational product candidates available on an expanded access basis, this policy will be updated with a hyperlink to the expanded access record on clinicaltrials.gov after such record becomes active.
As authorized by the 21st Century Cures Act, Censa Pharmaceuticals may revise this expanded access policy at any time. Additionally, the posting of this policy by Censa Pharmaceuticals shall not serve as a guarantee of access to any specific investigational drug by any individual patient.