Access to Investigational Medicines
To serve patients, Amgen engages in clinical research with the goal of obtaining regulatory approval of its products.
Clinical trials allow Amgen to evaluate investigational new treatments in volunteers in order to generate the safety and efficacy information needed to obtain approval of those treatments and make them available to the broader patient population. Outside of a clinical trial, access to Amgen’s investigational products would be considered under limited circumstances only, and as permitted by applicable law, in the following situations:
- Amgen may provide continued access to its investigational products to research participants once a clinical trial is complete.
- Amgen may provide physician-requested expanded access to its investigational products to patients with serious or immediately life-threatening diseases who lack other therapeutic options, cannot join an active clinical trial of the investigational product, and where the potential benefits of the investigational product are greater than the known risks in the disease indication (as described by the criteria below).
Criteria Used for Considering Requests for Expanded Access
- The patient has a serious or immediately life threatening disease or condition.
- There is no comparable or satisfactory alternative therapy for the disease or condition.
- Sufficient clinical evidence of safety and effectiveness in the indication has been established, the potential benefit justifies the potential risks, and the potential risks are not unreasonable within the context of the disease or condition.
- Product is under active development in the indication and expanded access will not interfere with the development of the product.
- Amgen has adequate supply of investigational product.
- There is a regulatory mechanism in the country or region to support expanded access.
Process for Requesting Expanded Access
A treating physician may request information about how to apply for access to one of Amgen’s investigational products by contacting Amgen Medical Information at email@example.com. All physicians who receive Amgen investigational product through expanded access are required to comply with all applicable laws and regulations, and contractual conditions, including those relating to safety reporting.