ACCESS TO INVESTIGATIONAL MEDICINES PRIOR TO REGULATORY APPROVAL
Biohaven Pharmaceuticals is dedicated to the development of innovative drugs targeting neurological diseases. We are 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. Patients entering clinical trials are required to meet specific criteria. For those patients who do not meet the criteria, or if a clinical trial is not available, Expanded Access (sometimes called compassionate use) may be a path for patients 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 patient has a serious or immediately life-threatening illness and there is no satisfactory alternative therapy
- The patient 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 patient’s condition
- The potential benefit of the investigational medicine to the patient 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. The requesting physician must meet the following criteria:
- Be medically qualified and licensed
- Agree to directly supervise treatment
- Be willing to comply with safety and monitoring requirements
- Be willing to comply with safety reporting requirements
- Be willing to obtain relevant health authority, for example the Food and Drug Administration (FDA), and IRB approval
- Comply with local laws and regulations
Patients for whom a request is made must meet the following criteria:
- Provide informed consent to the known and unknown risks of the investigational drug
- Comply with the prescribed treatment and associated visits
- Comply with safety and monitoring requirements
The above criteria are those that Biohaven will consider in determining whether to offer Expanded Access; however, Biohaven cannot make a guarantee that Expanded Access will be made available to a patient. If these criteria are met, Biohaven will consider Expanded Access requests from a treating physician, where allowed by local laws and regulations. All requests will be evaluated in a fair and unbiased manner. If the above criteria are met, a physician may request Expanded Access by contacting BHV0223.ExpandedAccess@EarlyAccessCare.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 a patient’s eligibility for Expanded Access.