Clinical Pipeline | Expanded Access
Expanded Access Policy
Edesa Biotech is dedicated to developing new therapies that have a positive impact on patient health. As a part of that commitment, we do our best to serve patients, their families and caregivers, and patient communities through education, empathy, and awareness.
Consistent with our mission to bring innovative medicines to patients with serious or life-threatening illnesses or conditions with unmet medical needs, we are focused on obtaining approval of our product candidates as soon as possible, consistent with regulatory requirements. Typically, that means enrolling and conducting the controlled clinical trials necessary to gain regulatory approvals so that we can make our medicines available broadly to patients. We believe this approach will best serve patients who could be helped by the therapies we are developing.
At the same time, we understand that at any given time there are seriously ill patients who are unable to participate in our clinical trials. Some of these patients may not have options for alternative therapies, including other approved and marketed therapies, or investigational therapies in trials being conducted by other sponsors.
In these circumstances, we will consider providing a requesting physician with pre-approval access to a specific Edesa Biotech investigational drug, for the treatment of an individual patient outside of a clinical trial, when certain conditions are met. These conditions include the following:
- The patient has a serious or life-threatening illness or condition and there is no comparable or satisfactory alternative therapy to treat the disease or condition;
- The potential patient benefit justifies the potential risks of the treatment use and those potential risks are not unreasonable in the context of the disease or condition to be treated, as determined by the treating physician;
- Providing the investigational drug for the requested use will not interfere with the initiation, conduct, or completion of clinical investigations that could support marketing approval of the expanded access use or otherwise compromise the potential development of the expanded access use;
- The investigational drug is in clinical development by Edesa Biotech, with sufficient data available to determine an appropriate dose and schedule for the patient’s specific condition;
- The patient does not qualify to participate in any clinical study of the investigational drug in a reasonable geographic location for the patient;
- A risk/benefit analysis, based on both the available clinical data as well as the requesting physician’s assessment of the individual patient’s condition and history, supports making the investigational drug available to the patient;
- Making the investigational drug available will not negatively impact or delay the conduct of clinical trials or regulatory review or approval of the investigational drug for broader patient access;
- Adequate supply of the investigational drug is available, without compromising other supply needs, including ongoing clinical development; and
- Taking into account any other relevant considerations, access to the drug is warranted.
We continually evaluate the benefit/risk profile of each of our investigational drugs based on evolving clinical data. Each product candidate under development is different. The fact that one investigational drug is made available for the treatment of a particular patient does not mean it will be made available in response to other requests on behalf of other patients whose circumstances and medical histories may be different, or that a different investigational drug will be made available under our policy.
Edesa Biotech is committed to evaluating all requests in a fair and equitable manner. All requests for access must be submitted by the patient’s treating physician. We may require more detailed information about the patient or the patient’s medical history in order to fully evaluate a request. The requesting physician must agree to obtain appropriate regulatory and ethics committee approvals, and must comply with all regulatory obligations, including obtaining patient informed consent, patient monitoring and safety reporting and, if required, institutional review board approval. Requests will be considered on a case-by-case basis; we will give each request careful consideration. There is no guarantee that requests will be fulfilled. More information for patients and physicians from the U. S. Food and Drug Administration on expanded access can be found here.
Physicians seeking pre-approval access for patients with no alternative treatment options should submit their requests to firstname.lastname@example.org. We regularly monitor these inquiries and will use our best efforts to acknowledge each submitted request within five business days after receipt.
We reserve the right to change our policy at any time and for any reason, including but not limited to a change in risk/benefit profile, a limited, reduced or inadequate supply of the investigational drug, or the commercial availability of our drug or other treatment alternatives.
We understand that patients, families, and caregivers face many challenges in the management of their health conditions. We hope that providing this summary of our expanded access policy will assist them in the management of their conditions.