SYNLOGIC Preapproval ACCESS POLICY
Synlogic is committed to pioneering innovative medicines to treat a wide range of diseases and conditions. Synlogic believes that the best way for patients to access medicines not yet approved or licensed by the U.S. Food and Drug Association (FDA) (“investigational medicines”) or another country’s health authority, is to participate in clinical trials, where outcomes are used to establish the safety and efficacy of the medicine. Information about Synlogic’s current clinical trials can be found at https://www.synlogictx.com/clinical-trails/ and www.clinicaltrials.gov.
We recognize, however, that patients and their healthcare providers may request access to investigational medicines outside the context of clinical trials, such as when patients do not qualify for participation in a clinical trial, including from other sponsors, and have exhausted other available treatment options. We understand these individuals’ desire for pre-approval access and the importance of providing access to investigational medicines when appropriate.
This policy sets forth Synlogic’s practices for providing pre-approval access to investigational medicines outside clinical trials to patients in the country from which the request is intended to be used. This policy applies to all Synlogic therapies that are under investigation but have not yet been approved or licensed in the country in which the patient resides. This policy also applies to the time period between regulatory approval of an investigational product and its commercial availability in a country.
Synlogic reviews all requests by qualified physicians for preapproval access on a case-by-case basis based on the following criteria:
- The disease or condition is serious or life-threatening as determined by their treating physician.
- The patient is not qualified for enrollment in a clinical trial for the investigational medicine.
- The patient has undergone appropriate standard treatments without success and there are no comparable or satisfactory treatment options available to treat the disease or condition.
- There is sufficient preliminary safety and efficacy data from clinical studies of patients to demonstrate that the potential benefit to the individual patient would likely outweigh the potential risks. Generally, a Phase I clinical trial must be complete for Synlogic to find sufficient preliminary safety and efficacy data to merit treatment.
- If there is a comparable or satisfactory treatment option available and the patient requests concurrent treatment with an investigational medicine, there must be sufficient preliminary safety and efficacy data from clinical studies to demonstrate that the potential benefit to the patient would likely outweigh the potential risks if concurrently treated with the investigational medicine.
- Synlogic plans to make the medicine available through normal prescription channels after its approval. Where it is expected that there is a need for ongoing treatment with one of our new medicines, this must be through normal health services once the new medicine is available for prescription.
- The provision of preapproval access will not delay, interfere with, or compromise the completion of a clinical trial or the review or approval of the drug by a regulatory authority and ultimately availability to all patients.
- Synlogic has the manufacturing capacity and supply necessary to provide access.
- The provision of preapproval access does not otherwise pose challenges that would reasonably preclude the practical administration of the investigational drug.
An interdisciplinary team at Synlogic will review requests on a case-by-case basis to determine whether access should be granted in light of the above criteria. We continually evaluate the benefit-risk profile of each of our investigational medicines based on evolving clinical data. Each investigational medicine under development is different and 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. Each request will be given careful consideration by Synlogic whose decisions are final.
In addition to the above criteria, all legal and regulatory requirements must be fulfilled. The patient/treating physician must agree to maintain records and release them as requested to Synlogic.
For patients in the U.S., FDA and an Institutional Review Board (IRB)/Institutional Ethics Committee (IEC) must approve the proposed preapproval access use. Outside the U.S., the applicable country-specific regulatory authorities and review boards should make such approvals. The patient/treating physician must be willing to carry out a protocol deemed appropriate by Synlogic including data collection and safety reporting under the appropriate regulatory standards. The patient must provide informed consent and the treating physician must be legally and professionally qualified to administer the investigational treatment. Preapproval access will not be provided where any of the above requirements are not fulfilled or where it is otherwise not permitted by federal, state, local, or international law. Preapproval access may also be discontinued at any time at the discretion of the treating physician, patient, or Synlogic based upon the above or other criteria.
Requests can be made by contacting Synlogic at firstname.lastname@example.org. Synlogic plans to acknowledge receipt of the request within three business days and communicate a decision to the requesting physician within seven business days once all necessary medical and other information is provided.
As provided by the 21st Century Cures Act, this preapproval access policy does not guarantee any patient the right to have access to Synlogic’s investigational medicines.