Expanded Access
Our Commitment
At NewAmsterdam Pharma, we are committed to developing our investigational medicines for dyslipdemia and cardiovascular disease. We encourage patients to participate in clinical trials of our investigational medicines whenever possible because clinical trials are designed to generate comprehensive safety and efficacy data that may lead to the approval and availability of new medicines for patients in need. At this time, we are not evaluating requests for compassionate access. If you have questions regarding the status of our development programs or regarding our criteria for evaluating requests for compassionate access, please contact us at access@NewAmsterdamPharma.com. Additional information regarding our expanded access process can be found below.
Our Expanded Access Policy
Patients are at the center of NewAmsterdam Pharma’s mission of discovering, developing, and delivering innovative medicines that address significant medical needs. Our goal at NewAmsterdam is to determine whether our investigational medicines are safe and effective, and if so, to advance them through the clinical trial and regulatory process as quickly and responsibly as possible. It is through clinical trials and the successful registration of our medicines with global health authorities that we will be able to make our potential medicines available to the greatest number of patients who might benefit.
We understand the urgency felt by patients and their families facing a serious or immediately life-threatening disease when there are no standard treatment options available or all treatment options have been exhausted. In the future, NewAmsterdam may consider providing access to our investigational medicines to patients with a serious or immediately life-threatening disease and for those who are unable to participate in one of our ongoing clinical trials. Our goal is to help as many patients as possible while maintaining our primary focus on moving our investigational medicines through clinical trials and ultimately toward regulatory approvals.
In the future, we may consider individual compassionate access requests for our investigational medicines that meet the criteria outlined below. For our investigational medicines that are in later stages of development, we may also consider opening broader expanded access clinical programs. The type of compassionate access or expanded access program can vary from country to country for many reasons, including national and local laws as well as health authority requirements. This may be the case even for the same investigational medicine. However, all requests for access to our investigational medicines outside of clinical trials must meet all of the below criteria in order to be considered.
Criteria
The patient must have a serious or immediately life-threatening disease for which there are no standard treatment options available or all treatment options have been exhausted.
The patient must not be eligible for ongoing clinical trials of the investigational medicine or must not be physically able to travel to a clinical trial site.
The investigational medicine must be in active clinical development in the disease with sufficient clinical data available to suggest that the drug may provide therapeutic benefit in that disease.
Requests for access to our investigational medicines must be made by a qualified physician who agrees to directly supervise treatment of the patient. The physician making the request must have made a determination that the probable risk to the patient from the investigational medicine is not greater than the probable risk from the disease. We will work with the patient’s physician to provide them with available information about the investigational medicine at the time of the request to enable this assessment. We will acknowledge receipt of these requests within 5 business days.
Providing the investigational medicine will not compromise or interfere with its clinical development, including the initiation, conduct, or completion of clinical studies.
There must be a sufficient amount of the investigational medicine available for the requested use after ensuring adequate supply for ongoing and planned clinical trials and other supporting work required for regulatory submissions.
Because we believe it is important to have clinical data regarding the potential benefits and risks of an investigational medicine in a particular disease, we are not supporting requests for compassionate access to our investigational medicines in diseases that we are not actively studying in clinical trials.
While we cannot guarantee compassionate or expanded access to our investigational medicines, NewAmsterdam Pharma will continuously evaluate all of our clinical programs in relation to these criteria and in the future will evaluate all requests individually. Appropriate health authorities, such as the U.S. Food and Drug Administration, the Institutional Review Board, or Ethics Committee at the patient's treating hospital or clinic must also review and approve the proposed use of the investigational medicine by the patient before NewAmsterdam Pharma can provide it. In addition, the submitting physician must agree to comply with regulatory obligations, including obtaining patient informed consent, patient monitoring, and safety reporting.
If you have a question regarding a request for access to one of NewAmsterdam Pharma’s investigational medicines that meets the above criteria, please send your inquiry to access@NewAmsterdamPharma.com.
You can learn more about our ongoing clinical trials by searching for “NewAmsterdam Pharma” or the name of the investigational medicine on https://www.clinicaltrials.gov/.
NewAmsterdam Pharma reserves the right to revise this expanded access policy at any time. The posting of this policy does not guarantee access to any investigational medicine by any patient.
1. This policy is required to be posted on the earlier of (1) the first initiation of a Phase 2 or Phase 3 study of the investigational drug, or (2) as applicable, 15 days after the drug receives a designation as a breakthrough therapy, fast-track product, or regenerative advanced therapy. See 21 USC § 360bbb-0(f).