Scope

This policy applies to provision of access to Inventiva’s investigational products that are not approved for any purpose in the country concerned by the request. This also includes the time period between regulatory approval of an investigational product and its commercial availability in any given country.

Overview

For new medicines to be legally approved for use, companies like Inventiva are required to evaluate their safety and effectiveness in clinical trials and submit trial results to regulatory agencies, like the United States Food and Drug Administration (FDA). To participate in a trial, patients must meet certain criteria.

Inventiva is focused on conducting clinical trials required by regulatory authorities to answer important scientific questions about the potential risks and benefits of our investigational products and to obtain regulatory approval and marketing authorization.

Inventiva endeavors to make investigational products available to patients with serious and life-threatening diseases who have exhausted other treatment options and where there is a reasonable expectation of benefit over risk as defined in this policy. In general, a treating physician, who has experience with the investigational product, and is able to comply with the requirements that are stated in this document, may apply for access to Inventiva‘s investigational products on behalf of their patient(s) by contacting EAP@inventivapharma.com.

Requests from physicians for expanded access are generally reviewed by Inventiva within 15 business days, and Inventiva’s responses are provided directly to the treating physician. Patients or non-healthcare professionals must contact their treating physician if they would like to access to Inventiva‘s investigational products.

Policy Statements

Any use of Inventiva’s investigational product outside a clinical study must be made in accordance with local laws and regulations governing such programs, as well as Inventiva’s policies and procedures.

• In general, where permitted by local regulation, an investigational product supplied via expanded access will no longer be provided by Inventiva once it becomes available via the local healthcare system or following discontinuation of the drug development program.
• Inventiva may decide not to provide an investigational product under this policy if Inventiva does not intend to market the product in the country in consideration.

Expanded Access Eligibility

At Inventiva, expanded access of an investigational product will only be considered if all of the following conditions documented by the treating physician are met:

• The disease or condition being studied is serious or immediately life-threatening;
• There are no adequate alternate therapies or clinical trials available;
• There is sufficient preliminary rationale, dosing, activity and safety data for the investigational product in order for Inventiva to make a benefit-risk analysis consistent with the establishment of an expanded access program;
• A request is received directly from a patient’s treating physician who has experience with the Inventiva’s investigational product (i.e., has served as an investigator on a clinical trial of the Inventiva’s investigational product);
• The provision of the Inventiva’s investigational product will not interfere with or compromise the clinical development of the product as this may preclude making a safe and effective treatment available to patients;
• The patient must be ineligible for participation in any actively enrolling Inventiva’s clinical trial of the investigational product;
• Inventiva has an adequate supply of the investigational product outside of clinical trials;
• The applicable regulatory agency and Institutional Review Board review and approve the use of the Inventiva’s investigational product for the particular patient.

The above criteria are those that Inventiva will consider in determining whether to authorize expanded access. Inventiva cannot guarantee that an expanded access program will be available, or that the investigational product will be available for a particular patient even if an expanded access program is available.

Treating Physician Criteria and Responsibilities

In addition to the criteria listed above, the treating physician(s) attending to the patient(s) who is/are receiving an investigational product through expanded access must be properly licensed and fully qualified to administer the product.

The treating physician must have experience with the investigational product and agree in writing to comply with:

• All applicable country-specific legal and regulatory requirements related to providing an investigational product under expanded access; and
• All Inventiva’s requirements in terms of medical monitoring, safety reporting, data collection, drug supply/administration and protection of intellectual property. A treating physician may submit questions or requests regarding expanded access to EAP@inventivapharma.com.

Requesting Access

For access to an investigational product via expanded access, the following steps must be followed:

• Patient’s qualified treating doctor must make a formal request to EAP@inventivapharma.com;
• The eligibility criteria and treating physician’s criteria and responsibilities must be reviewed and satisfied;

Only requests from a treating physician will be reviewed by Inventiva.

Reviewing Requests for Access

Inventiva is committed to ensuring a fair and impartial evaluation of each valid request for access to our investigational products. All decisions are based solely on clinical circumstances and the principles outlined above.

Requests from physicians for expanded access are generally reviewed by Inventiva within 15 business days of receipt of the formal request from the treating physician with all required supporting medical documentation. The regulatory agency in the country of the request and local ethics committee must also approve the proposed use of the investigational product.

Learn More

To obtain additional information about expanded access to Inventiva investigational products, please visit www.clinicaltrials.gov.

Inventiva reserves the right to amend or rescind this policy at any time without prior notice. This policy is not a guarantee of access to any Inventiva’s investigational products.