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Expanded Access Policy

Expanded Access Policy

For patients living with life-threatening diseases, addressing their unmet medical needs is important to RedHill.


Access to Investigational New Drugs Intended to Treat Serious, Life-threatening Diseases

For new medicines to be legally approved for use, companies are required to evaluate their safety and effectiveness in clinical trials and submit results to regulatory agencies that will ultimately decide whether the potential benefits outweigh the potential risk.   As such, to protect patients, RedHill Biopharma usually restricts access to our investigational new drugs to patients participating in clinical trials. 

Expanded access, or compassionate use, is an individual patient use of an investigational new drug outside of a clinical trial. Expanded access is sometimes possible when the investigational new drug is needed to treat a serious or life-threatening condition and there is some clinical evidence suggesting that it might be effective in that condition.

This page explains RedHill’s policy and the options that may be available to patients in these circumstances.

Because clinical trials generate data regarding the efficacy and safety of RedHill’s investigational drugs, wherever possible, use of an investigational new drug by a patient is preferable as part of a clinical trial. These data help determine whether the benefits of the investigational new drug outweigh the risks, whether it should be approved by the regulatory authorities for marketing and, if approved, where and how it should be used.

The first step for someone seeking access to RedHill’s investigational new drugs is to review our ongoing clinical trials (see link below) to understand if the patient might be eligible to participate in one of these trials. If it is not possible for a patient to enroll in a clinical trial and there are no other standard therapies that are appropriate, RedHill will evaluate, on a case-by-case basis and depending on eligibility criteria, whether it may provide access to the investigational new drug for individual patient use.

Every country has unique regulatory mechanisms to provide expanded access to investigational products and, as a result, regional variations in expanded access might occur.

It is important to remember that investigational new drugs have not yet received regulatory approval; therefore, their potential risks and benefits are not yet fully established. Physicians and patients should consider all possible benefits and risks when looking to access  an investigational new drug.

1.0 Clinical Trials

To participate in a trial, you must meet certain criteria. For those who meet these criteria to join a clinical trial, participation offers the chance to contribute to medical research that may benefit many others as well as the participant. Participation in a clinical trial comes with certain risks; that is why “informed consent” is a required step in the process of enrolling.

 

2.0 Expanded Access Criteria

RedHill criteria for considering requests for expanded access include:

  • The patient is suffering from a life-threatening condition.
  • The patient is not eligible or able to participate in a clinical trial sponsored by Redhill.
  • A strong rationale or clinical data support the potential benefits of administration of the investigational medicinal product to the patient for that life-threatening condition could outweigh the potential risks.
  • The patient’s physician has determined that treating the patient with the investigational product is in the patient’s best interests.
  • The investigational medicinal product will be administered in accordance with applicable laws and regulatory requirements of the country where the patient is treated.
  • The investigational product is available in sufficient quantity to enable a reasonable course of treatment.
  • Providing the investigational new drug would not interfere with ongoing clinical trials or regulatory submissions and the investigational new drug’s eventual approval prospects.
  • No alternative treatment is available.


Treating physicians are required to submit expanded access requests on behalf of patients to RedHill at in ExpandedAccess@RedHillBio.com in addition to obtaining the local regulatory approval for the proposed use of the investigational medicinal product.  Please note that the application can only be submitted by a physician licensed where the patient is to be treated.

Medical professionals at RedHill who are familiar with the data available on the investigational new drug evaluate each request and respond based on the scientific evidence available at the time of the request and the criteria listed above.

All individual patient use requests submitted by a treating physician must include:

  • Date of request
    Requesting physician’s name, contact information address (including country), and professional designation (i.e., MD, DO) and qualifications to administer the investigational therapy
  • Name of the requested investigational medicinal product along with physician’s intended treatment plan, including therapeutic indication and expected duration of treatment
  • Medical rationale for request including an explanation for why alternative therapy cannot be used, why the patient does not qualify for a clinical trial, and why use of the investigational drug is in the patient’s best interest


A preliminary response acknowledging receipt of the request for expanded access will typically be sent to the requesting physician within 5 business days. The decision indicating approval, a request for additional information or the rationale for non-approval will be received by the requesting physician after review by our medical professionals. RedHill cannot guarantee that it will grant any request, even if the criteria are met, but it will review each request carefully. If you have any additional questions, please contact Info@RedHillBio.com.

Resources:
U.S. Food and Drug Administration Expanded Access Website (link is external)