Prothena has determined, after assessing these considerations, that compassionate use cannot currently be offered for any of its investigational drugs. We will be re-evaluating this policy periodically.
If and when Prothena provides compassionate use for a particular investigational drug, the company will review each individual request for compassionate use and respond to the physician who makes the request. During this process, Prothena 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 a compassionate use program.
If you have questions about Prothena’s Compassionate Use Policy, please contact Prothena’s medical information at firstname.lastname@example.org.