Akari Therapeutics (“Akari” or “Company”) is committed to developing new therapies to address the unmet medical needs of patients with autoimmune and inflammatory diseases by conducting rigorous clinical trials and obtaining marketing approval by global regulatory authorities.
Akari will consider providing our investigational medicines to patients through their physicians if enrollment in a clinical trial is not possible and there is no alternative therapy to treat the condition. In these situations, the Company will consider providing pre-approval access to our investigational medicines once the medicines have completed Phase 1 clinical development and when certain conditions are met. These conditions are:
- The patient to be treated has a serious or immediately life-threatening condition and there is no appropriate alternative therapy
- The patient has undergone appropriate treatment with standard of care and is no longer achieving benefit from treatment and no comparable or satisfactory alternative treatment is available or exists to treat the condition
- The patient must meet all other pertinent medical criteria established by the Akari medical team for access to the investigational or unlicensed product, and this will be documented in a mutually signed attestation between the treating physician and a representative of the Akari medical team
- The patient is not eligible for, or cannot access, any ongoing clinical trials
- The potential benefit of the investigational medicine to the patient outweighs the potential risk, which is evaluated by a patient’s physician and discussed in detail with the patient
- There is an adequate supply of the investigational medicine, in that Akari has surplus investigational medicine exceeding what is required for the ongoing clinical trials
- Providing the investigational drug will not interfere or delay clinical trials that could support a medical product’s development or marketing approval and availability to other patients in need
Requests for Akari’s investigational medicines must come from the treating physician. The requesting physician must be willing to obtain the appropriate and necessary approvals. The physician must also comply with various regulatory obligations, including obtaining patient consent, patient monitoring, safety, and outcome reporting as required by law and/or Akari. The Company continually evaluates the benefit-risk profile of our investigational drugs and may require additional information from a treating physician to fully evaluate a request.
Akari is committed to providing a fair evaluation of all requests. Requests are reviewed and decisions are made on a case-by-case basis. Akari makes no guarantees about current or future expanded access. Access may or may not be granted, even when eligibility criteria are met.
Physicians who would like to seek pre-approval access to an Akari investigational medicine should submit their requests to expandedaccess@akaritx.com. We regularly monitor this mailbox, and we will acknowledge each submitted request within a target of 7 days after receipt.
