If and when we provide expanded access for a particular investigational drug, we will review each individual request on a case-by-case basis in a fair and equitable manner and respond to the physician who makes the request. During this process, we will need to ensure that:
- The patient suffers from a serious or immediately life-threatening disease or condition.
- Granting access will not interfere with current clinical trials or regulatory filings.
- The request is made through a clinician expert in the therapeutic area who has weighed the potential benefits and risks of providing the investigational drug to the patient and found that the potential benefit outweighs the risk.
- The patient is unable to participate in or does not qualify for any ongoing or planned clinical trials.
- The patient has exhausted other therapies that may help him/her.
- Any other pertinent medical criteria for access to the investigational product, as established by the Prothena clinically or medically responsible individual.
The above are general requirements, and specific requirements will be applied for a given investigational drug or clinical program if and when Prothena initiates an expanded access program.
Note that investigational drugs have not yet been approved or cleared by regulatory authorities and regulatory authorities have not found these products to be safe and effective for their specific use. Furthermore, investigational drugs may, or may not, be effective in the treatment of the applicable condition, and use of such investigational drugs may cause unexpected serious side effects.
– Patients should consult with their treating physician about their eligibility to enroll in any of Prothena’s clinical trials. To get more details about Prothena’s clinical trials, please visit the “Clinical Trials” page on Prothena’s website or on www.ClinicalTrials.gov. If you are a physician who has questions about Prothena’s investigational therapies, please contact us at firstname.lastname@example.org.
– The publication of this policy by Prothena is not a guarantee of access to any specific investigational drug by any individual patient. Prothena may revise this expanded access policy at any time.