Expanded Access Policy
Priovant Therapeutics, Inc. ("Priovant") is committed to developing and providing innovative and transformative products to address significant unmet medical needs and significantly improve the quality of life for patients who suffer from autoimmune diseases.
Priovant conducts clinical trials to assess the safety, efficacy, and other important scientific information about its investigational products. The establishment of safety and efficacy by regulatory agencies such as the Food and Drug Administration (FDA) is required by law before these investigational products can be made generally available to all patients. Priovant encourages patients to be aware of opportunities to participate in clinical trials and believes that participating in clinical trials is the best way for patients to access investigational products before regulatory approval.
In some cases, it may not be possible for a patient to participate in a clinical trial even when all other available medical options have been exhausted, and the patient may work with his/her physician to seek expanded access (also known as "compassionate use") to allow the patient access to an investigational product. Expanded access refers to the use of an unapproved investigational product when the primary purpose is to diagnose, monitor, or treat a patient, and not as part of a clinical trial to obtain information about safety and efficacy of that product needed for approval. It's important to remember that investigational drugs have not yet received regulatory approval; therefore, their conclusive risks and benefits are not yet established. Doctors and patients should consider all possible benefits and risks when seeking expanded access to an investigational drug.
Priovant will consider individual patient expanded-access requests on a case-by-case basis and in accordance with all applicable laws and regulations. Expanded access may not be available in some cases due to, for example, unavailability of product, or for other reasons. This policy will be reviewed regularly as product development continues, and any changes to the policy will be updated in this location. The following is additional information regarding Priovant's expanded access policy in accordance with the 21st Century Cures Act.
The FDA has prepared US guidelines about expanded access, including a "question and answers" guideline. In Europe, the EMA has also provided EU recommendations about Compassionate Use. Other global health authorities may also have specific recommendations for expanded access/compassionate use programs that may allow some patients access to investigational products outside of a clinical trial. Priovant is committed to complying with all applicable laws, regulations, and requirements in the applicable region(s).
If you have any questions regarding Priovant's expanded access policy or are interested in participating in a clinical trial, please contact (212) 634-9743 or by email at email@example.com.
Procedure for Requesting Expanded Access
The treating physician requesting expanded access must contact Priovant directly with the basis for the request. The treating physician should include their contact information so that Priovant may follow up with them directly.
It is important to note that the patient's physician must oversee all aspects relating to the potential use of the drug under expanded access (these may include activities like regulatory compliance, IRB approval, patient consent and treatment, adverse event management, and reporting).
If you contact Priovant as described above, Priovant anticipates that we will acknowledge receipt within ten (10) business days or less.
Priovant may revise this expanded access policy at any time. Additionally, the posting of this policy by Priovant shall not serve as a guarantee of access to any specific investigational product by any individual patient.