Kiniksa Pharmaceuticals, Ltd. (Kiniksa) is focused on developing therapeutic medicines for patients suffering from debilitating diseases with significant unmet medical need and is conducting clinical trials to support this effort. Clinical trials allow Kiniksa to evaluate investigational products in order to generate the efficacy and safety information needed to obtain approval of those treatments and make them available to the appropriate patient population. Information regarding Kiniksa’s ongoing clinical trials can be found within the pipeline section of our website or on .
However, Kiniksa understands that not all patients may be eligible for its clinical trials and may not have options for alternative therapies, including investigational therapies in trials being conducted by other sponsors. For those patients, Kiniksa will consider providing access to a physician who requests access to a specific Kiniksa investigational drug for the treatment of an individual patient outside of a clinical trial if certain criteria are met. Outside of a clinical trial, Kiniksa will consider providing access to its investigational products in the situations below under limited circumstances only, and if permitted by applicable law.
Kiniksa uses the following criteria, in its sole judgment, to help evaluate requests for Expanded Access:
Kiniksa evaluates the benefit-risk profile of its investigational products based on emerging clinical data. Each of Kiniksa’s development programs is different. Making one investigational product available for the treatment of a specific patient does not mean that it will be made available in response to other requests as individual patient circumstances and medical histories differ. As such, each request will be considered on a case-by-case basis.
Kiniksa is committed to evaluating all requests in a timely, fair, and unbiased manner. Patients interested in seeking Expanded Access to a Kiniksa investigational product should talk to their treating physician. The treating physician may request information about applying for access to one of Kiniksa’s investigational products by contacting Kiniksa via email (ExpandedAccess@kiniksa.com).
Kiniksa will typically acknowledge receipt of a request for Expanded Access within 3 business days. Kiniksa will review all Expanded Access requests in consideration of the above criteria and may require more detailed information in order to fully evaluate individual requests.
All physicians who receive Kiniksa investigational product through Expanded Access are required to comply with all applicable laws and regulations and contractual conditions requested by Kiniksa, including, but not limited to, obtaining patient consent, patient monitoring and safety reporting, and obtaining appropriate regulatory and ethics committee approvals from their corresponding institution(s). Each request will be given careful consideration by a Kiniksa Review Team whose decisions are final.