Expanded Access Policy
- Apollo Therapeutics (Apollo) is focused on developing the investigational product camoteskimab for the treatment of patients with Still’s disease and potentially other indications. Camoteskimab is currently undergoing clinical evaluation of its efficacy and safety for use in humans, which has not yet been established. If these clinical trials and other tests provide substantial evidence of efficacy and safety, Apollo plans to seek marketing approvals from regulatory health authorities to make camoteskimab commercially available for the treatment of patients outside of the clinical trial setting.
- At the present time, the primary way that patients may receive camoteskimab is by enrolling in clinical trials sponsored by Apollo. Information about Apollo’s ongoing clinical trials can be found on www.ClinicalTrials.gov by searching “Apollo Therapeutics” in the “sponsor” field under the heading “Advanced Search.”
- We recognize that there may be situations where a patient with a serious or life-threatening condition may not qualify for an Apollo-sponsored clinical trial. In those cases, the patient’s healthcare provider may seek access to camoteskimab outside a clinical trial setting. Drug manufacturers like Apollo may in some circumstances make unapproved drugs available for such patients. Such availability, generally referred to as “expanded access” or “compassionate use,” is subject to various legal requirements intended to protect the rights, safety, and welfare of patients.
- Apollo evaluates expanded access requests on a case-by-case basis, consistent with the policy set forth below. Apollo retains sole discretion in deciding whether to grant an expanded access request and may modify or reverse such decisions at any time. Expanded access is subject to Apollo’s continuing evaluation of safety and effectiveness data about the investigational drug, as well as other considerations such as financial sustainability, product inventory, manufacturing capacity, and clinical development priorities. Apollo may revise this policy at any time.
Contact Information and Request Process
- Questions about Apollo’s expanded access policy and requests for expanded access should be sent to: firstname.lastname@example.org.
- An expanded access request must be submitted by a licensed physician who is in a treatment relationship with the patient for whom the investigational product is being requested. Such requests should provide sufficient supporting detail to enable us to evaluate the request. Requests must include the physician’s contact information so that we may follow up with the physician directly. If a patient submits a Program Request to Apollo directly, Apollo will ask that the patient’s physician resubmit the request.
When evaluating an expanded access request, Apollo will consider whether:
- The patient has a serious or life-threatening disease or condition;
- There are no comparable or satisfactory alternative treatments available to the patient;
- The patient is not eligible for an ongoing or planned Apollo Therapeutics sponsored clinical trial or any other clinical trial of an investigational product for the patient’s condition;
- Sufficient preliminary evidence of safety and effectiveness in the indication has been established and the potential benefit to the patient justifies the known or potential risks;
- There is adequate supply of the investigational product to meet the needs of the request without adversely affecting company sponsored clinical trials;
- The use of the investigational product will be monitored and controlled appropriately and adequately by a licensed physician who is qualified to administer the investigational product in a safe manner and who practices at a facility that has the capability, including adequate equipment and personnel, to provide any care for the patient needed in connection with the administration of such product;
- The patient meets any other relevant medical criteria for expanded access to the investigational product, as determined by Apollo; and
- The expanded access request, and Apollo’s grant of the request, would be compliant with applicable local, state/provincial, and federal/national laws and regulations, as well as industry standards.
We anticipate an initial response to expanded access questions or requests within 10 business days of receipt, but it may take longer. The time required to respond in an individual case may vary based on a variety of factors.