Policy for Expanded Access to Investigational Medicines
Expanded Access to Investigational Medicines
Nektar is focused on and committed to bringing new medicines to patients with debilitating diseases. As part of that commitment, Nektar conducts (either alone or with a partner) clinical trials of our investigational medicines to demonstrate their safety and effectiveness for patients. The important data generated from these clinical trials are integral to obtaining regulatory approval of our medicines and represent the best and most efficient way to make them widely available to patients. Thus, whenever possible, Nektar will refer an individual requesting access to our investigational medicines to an appropriate clinical trial. Clinical trials enable rigorous systematic evaluation of an investigational medicine and allow for close monitoring of enrolled patients.
Clinical trials, including eligibility criteria, are listed at www.clinicaltrials.gov. Patients interesting in learning if enrollment in a clinical trial is an option for them should consult with their treating physician.
Nektar understands that, in some rare cases, there will be patients with a serious and immediately life-threatening disease for which no satisfactory treatment alternative exists, and for whom it is not possible to participate in a clinical trial. In these very specific circumstances, Nektar may consider providing our investigational medicines outside the clinical trial setting. These situations are often referred to in various ways, including expanded access, early access, pre-approval access, compassionate use and emergency use.
How Expanded Access Works at Nektar
Making decisions for expanded access to our investigational medicines is always complex. Nektar endeavors to make these decisions as ethically and fairly as possible, taking into consideration the particulars of each patient's case, the available medical and scientific information, and the probability and timing of a regulatory approval. A top priority is always ensuring that Nektar is not putting any patient at risk for unnecessary harm.
Thus, all decisions will be guided by the following principles:
- the request has been made by a qualified and licensed physician with expertise in the relevant area of medical practice;
- the request is for a Nektar investigational medication currently under clinical development or pending regulatory approval;
- the patient does not qualify for participation in ongoing or pending clinical trials; the patient to be treated has a serious and immediately life-threatening disease and there is no satisfactory treatment alternative;
- the patient's underlying medical conditions do not pose safety risks that have not been sufficiently studied;
- the patient's condition is of a type and stage commensurate with the indication for which the investigational medicine is likely to be approved;
- there is clinical evidence -- typically after Phase 3 data is available -- of effectiveness and safety of the investigational treatment for that patient's condition;
- the potential benefit of the investigational medicine to the patient is greater than the potential risk;
- there is an adequate supply of the investigational medicine;
- it has been established that the necessary facilities and resources are (or will be) in place to ensure the investigational medicine can be safely and correctly administered, and that the therapy with the investigational medicine will be sufficiently monitored and managed, and further that the reporting of side effects and patient experience will occur; and
- it has been established that access to the investigational medication will not compromise future or ongoing clinical trials in a way that may delay access to such investigational medication to other patients.
Procedure to Request Expanded Access
If a request for expanded access to an investigational medicine originates from a country in which Nektar has partnered with another company, the request for expanded access should be originated by a licensed physician on behalf of the patient and directed to the Nektar-partnered company.
Otherwise, a request for expanded access to a Nektar investigational medicine must originate directly from a licensed physician on behalf of his or her patient and should be forwarded to Nektar at ExpandedAccess@Nektar.com. The requesting physician must agree to obtain appropriate regulatory and ethics committee approvals, as applicable, and to comply with all other safety, monitoring, reporting, and patient consent requirements defined by Nektar.
Nektar anticipates acknowledging receipt of requests for expanded access orally or in writing within five (5) business days.