Pre-Approval Access to Investigational Products Policy

At AbbVie, we are passionate about developing advanced therapies to help address the world’s greatest health challenges. We also are committed to providing access to therapies that are not yet approved for use to people who are suffering from a serious or life-threatening illness or condition and might potentially benefit from these products.

To do that, AbbVie has developed a Pre-Approval Access to Investigational Products Policy. It outlines important considerations we take into account when evaluating a doctor’s request to use investigational products in a patient with a serious or life-threatening illness or condition.

We created this policy so we can make an appropriate medical decision about access to investigational products as quickly and as appropriately as possible.

Who this policy covers

Our policy applies to requests on behalf of individual patients (Single-Patient Access) and to certain groups of patients with similar characteristics (Multi-Patient Protocol Access). A Pre-Approval Access program may also be referred to as Expanded Access, Compassionate Use or Named Patient Basis programs, as defined by local regulations. While our policy outlines the general criteria for consideration, each case is unique and will be considered on an individual basis.

Why we did this

The primary option for patients to get access to investigational products is to participate in a clinical trial. Patients and physicians can learn more by reviewing information on current or planned clinical trials by visiting the U.S. National Institutes of Health website and the EU Clinical Trials Register website.

We recognize, there are extraordinary circumstances where access to these investigational products outside of a clinical trial is appropriate. Under our Access to Investigational Products Policy, a patient’s doctor can request consideration for access if three basic criteria are met:

  • The patient suffers from a serious or life-threatening illness or condition
  • There are no other suitable treatment options
  • The patient does not qualify for ongoing clinical trials

Other things we consider

Two other important factors play a role in our consideration of each patient request.

The first is to ensure that the potential benefits of the product outweigh the risks to the individual patient. Physicians consider this before they prescribe any therapy for a patient; it’s absolutely vital in these serious cases that an investigational product doesn’t add new or unreasonable risks for a patient.

The second is to ensure that providing access under this policy doesn’t have a negative impact on clinical trials. Such an impact would potentially delay approval and broad access so that a new drug may be offered to as many patients as possible.

Making a request

Requests for access to investigational products under development and prior to approval under this policy must be made by Treating Physicians. Treating Physicians should contact AbbVie via this link. Complete the necessary fields and submit. Following submission, you can expect to receive the necessary forms to begin the request process.

Our commitment

Because we are committed to addressing the world’s greatest health challenges, AbbVie takes requests for access under this policy very seriously. We will treat every request with respect, dignity and in a way that protects the privacy of the patient. We will consider each request carefully, individually and fairly. And once we have all the necessary information, we will strive to provide a decision as soon as we can.

If you have questions about our policy, please consult the below FAQ.

Frequently asked questions