ACCESS TO MEDICINES PRIOR TO REGULATORY APPROVAL
Biohaven is dedicated to the development of innovative drugs targeting neurological and neuropsychiatric diseases and advancing therapies to address conditions with unmet medical need. Well-designed clinical trials are the best way to understand a drug’s effectiveness and safety and are necessary to obtain approval for a medicine.
Participation in clinical trials is critical to the development of new medicines and people entering clinical trials are required to meet specific criteria. For those who do not meet the criteria, or if a clinical trial is not available, Expanded Access, also called compassionate use, may be a path to receive our investigational medicines.
Biohaven may consider Expanded Access requests if the following factors are met:
- The investigational drug is being studied under an appropriate regulatory authorization
- The person has a serious or immediately life-threatening illness and there is no satisfactory alternative therapy
- The person is unable to participate in a clinical trial due to eligibility criteria or other reasons
- There is preliminary clinical evidence of effectiveness and acceptable safety of the investigational treatment for that condition
- The potential benefit of the investigational medicine is greater than the potential risk
- There is an adequate supply of the investigational medicine to support the clinical trials and the expanded access request, until and if the drug becomes commercially available
Only a physician can request Expanded Access on behalf of their patient. A physician may request Expanded Access by contacting Expanded.Access@biohavenpharma.com.
Biohaven will acknowledge the request for Expanded Access within 2 business days. We may request additional information to assist with patient eligibility for an investigational medicine. All information submitted as part of a request will be maintained in the strictest of confidence and used solely for evaluating eligibility.