Prothena has determined, after assessing these considerations, that expanded access cannot currently be offered for any of our investigational drugs. We periodically re-evaluate this policy and its application to our study drugs.
If and when we provide expanded access for a particular investigational drug, we will review each individual request and respond to the physician who makes the request. During this process, we will need to ensure that:
- Granting access will not interfere with current clinical trials or regulatory filings.
- The patient does not qualify for any ongoing or planned clinical trials.
- The request is made through a clinician expert in the therapeutic area who has weighed the benefit and risk of providing the investigational drug to the patient.
- The patient has exhausted other therapies that may help him/her.
The above are general requirements, and specific requirements will be generated for a given investigational drug or clinical program if and when Prothena initiates an expanded access program.
If you have questions about Prothena’s Expanded Access Policy, please contact us at email@example.com.