Before new medicines or treatments can be made available to patients, well-controlled and regulated clinical trials must be conducted to determine the safety and efficacy of the product. However, there are instances where it is not possible for all patients with serious or life-threatening conditions to participate in a trial.
In cases where a patient has been treated with approved medicines without success and the physician believes that the benefits of treatment with an Allergan investigational product outweighs the risks, Allergan has a pre-approval access process. “Pre-Approval Access” terminology at Allergan includes all locally defined programs such as compassionate use, expanded access and others.
Pre-approval access allows physicians to reach out to Allergan and request access to an investigational product before the product has received regulatory approval and is commercially available, provided it is allowed by the applicable local laws.
Allergan requires all the following criteria are met to consider providing pre-approval access to a patient:
- The patient is suffering from a serious or life-threatening disease or condition
- The request must come from the patient’s qualified treating physician
- In the medical opinion of the treating physician, there is no other available medication/treatment (either commercial or via a clinical trial for which the patient would be eligible to participate in) to treat the disease/condition and all other treatment options have been used and are not effective or able to be tolerated by the patient
- The potential benefit to the patient outweighs the risk of the new medicine
- There is a clear rationale for which, in his/her medical opinion, the treating physician believes the patient will benefit from the treatment based on sufficient clinical data to support the safety and efficacy of the requested medication and dose
- The requested medication must be part of an ongoing development program
- The request will not in any way put at risk the ongoing development program
- Requests for special populations that may not have been studied to date (i.e. renal failure) will not be granted approval
- For pediatric requests, there must be sufficient clinical data to support the safety and efficacy of the requested medication and dose in the pediatric population